Principal Systems Engineer - Olympus Corporation of the Americas
Westborough, MA
About the Job
Working Location: MASSACHUSETTS, WESTBOROUGH
Workplace Flexibility: Onsite
_For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. _ __
Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus (https://www.olympusamerica.com/careers) .
_Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate._
Job Description
The Principal R&D Systems Engineer will lead or support Systems Engineering aspects on new product development efforts within the Olympus Surgical Technologies of America (OSTA) organization. The ideal candidate will be a hands-on project and multi-disciplinary technical leader with a strong systems design and integration background. The candidate will be looked upon as a subject matter expert (SME), and will provide project and engineering leadership in all phases of device development, as well as ensure compliance to applicable Design Controls, Product Security, and Cybersecurity policies. Areas of focus will include identification of user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, product security, cybersecurity, and equipment development oversight.
Extensive knowledge of medical device design control requirements, system design and software and hardware integration and testing, and design for manufacturability and testability is required. Deep understanding of medical device standards, and experience in their application, is required. This position is expected to provide leadership/mentorship to cross functional teams, and less experienced engineers/technicians.
Job Duties
+ Provide project and technical leadership to cross functional teams including external partners for projects through conceptualization, development, product registration and commercialization
+ Establish and foster strong collaborative relationships with internal and external design/development partners, manufacturing partners and service providers. Provide critique and design guidance to ensure proper implementation and traceability of design outputs as compared to design inputs.
+ Work closely with Marketing in collection of user needs/feedback on product requirements and concepts
+ Lead the requirements development and management process, incorporating risk management elements as required.
+ Ensure compliance to product security and cyber security policies, and support efforts to author local SOP’s to ensure compliance.
+ Support the optimization of design control elements to comply with medical device regulations.
+ Implement product design with the intention of optimizing design for manufacturability and testability
+ Consider Cost of Goods and lifecycle when selecting components for device designs.
+ Develop engineering solutions, investigate competing technologies while considering the patent landscape, and protect engineering solutions by filing timely invention disclosures and working closely with the IPLegal team as needed
+ Establish and maintain detailed project plans, define risks and recommend contingency plans as required.
+ Provide support of Risk Management activities, working with Design Assurance
+ Lead all technical project execution activities and oversee the development of statistically sound design verification protocols/reports, design validation, and delivery system qualification activities
+ Lead the system safety certification process to standards such as EN60601-1, EN60601-1-2. Ensure software is developed in compliance to the methodologies of EN 62304.
+ Provide technical support to Marketing for technical brochures, training programs, and technical presentations to customers and the sales force
+ Maintain knowledge of technical product landscape, competitive products and procedural trends for target procedural areas
Job Qualifications
Required:
+ Bachelor’s degree in Engineering or the equivalent in years of industry experience.
+ Minimum years of related experience: 9 years with BS, 8 years with MS, or 5 years with PhD
+ Must have extensive working knowledge of, and experience in applying / developing, products in compliance with FDA and international requirements, including 820-CFR, ISO14971, IEC60601, GMP and other standards as they relate to the development and manufacture of medical devices.
+ Capable of developing all deliverables required to document the product design with appropriate specificity to enable high volume manufacturing with high quality.
+ Proficient in Microsoft Windows Office applications including MS Outlook, MS PowerPoint, MS Project, Visio, etc..
+ Solidworks working knowledge. Proficient in the creation and critical review of engineering drawings, tolerancing and tolerance analysis.
+ Knowledge of common manufacturing methodologies, technologies, and materials employed in medical devices.
+ Ability and experienced in approaching challenging and/or ambiguous engineering problems with scientific logic and problem solving skills. Ability to communicate complex technical concepts clearly and concisely is required.
Preferred:
+ Established track record of leading Medical Device development and/or sustaining engineering efforts utilizing a stage-gate process. Experience in hand held electro-mechanical devices is preferred.
+ Experience applying good judgement to make timely decisions as well as exhibit the ability to balance risk vs. benefits in a variety of situations.
+ Ability to effectively work within a requirements management system (e.g., JAMA, Doors) preferred.
+ Experience in the practical application of statistics and working knowledge of a statistical analysis package (Minitab).
+ Must be able to collaborate effectively with others, work well within cross-functional teams and across multiple sites, as applicable.Must be capable of effectively directing project teams on multiple work streams in parallel and leading teams towards accomplishment of objectives.Must be able to communicate effectively at all levels, both verbally and in writing. Strong presentation skills and the ability influence. Must have a positive attitude and capable of motivating teams / team members to accomplish efforts in a timely manner and with high quality.
Why join Olympus?
_We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture._
Equitable Offerings you can count on:
+ Competitive salaries, annual bonus and 401(k)* with company match
+ Comprehensive medical, dental, vision coverage effective on start date
+ 24/7 Employee Assistance Program
+ Free live and on-demand Wellbeing Programs
+ Generous Paid Vacation and Sick Time
+ Paid Parental Leave and Adoption Assistance*
+ 12 Paid Holidays
+ On-Site Child Daycare, Café, Fitness Center
Connected Culture you can embrace:
+ Work-life integrated culture that supports an employee centric mindset
+ Offers onsite, hybrid and field work environments
+ Paid volunteering and charitable donation/match programs
+ Diversity Equity & Inclusion Initiatives including Employee Resource Groups
+ Dedicated Training Resources and Learning & Development Programs
+ Paid Educational Assistance
*US Only
Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?
Learn more about our benefit and incentives (https://www.olympusamerica.com/careers/benefits-perks) .
The anticipated base pay range for this full-time position working at this location is $131,345.00 - $183,883.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.
At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .
Olympus is dedicated to building a diverse, inclusive and authentic workplace
We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.
Let’s realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Applicants with Disabilities:**
As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Research and Development
Workplace Flexibility: Onsite
_For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. _ __
Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus (https://www.olympusamerica.com/careers) .
_Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate._
Job Description
The Principal R&D Systems Engineer will lead or support Systems Engineering aspects on new product development efforts within the Olympus Surgical Technologies of America (OSTA) organization. The ideal candidate will be a hands-on project and multi-disciplinary technical leader with a strong systems design and integration background. The candidate will be looked upon as a subject matter expert (SME), and will provide project and engineering leadership in all phases of device development, as well as ensure compliance to applicable Design Controls, Product Security, and Cybersecurity policies. Areas of focus will include identification of user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, product security, cybersecurity, and equipment development oversight.
Extensive knowledge of medical device design control requirements, system design and software and hardware integration and testing, and design for manufacturability and testability is required. Deep understanding of medical device standards, and experience in their application, is required. This position is expected to provide leadership/mentorship to cross functional teams, and less experienced engineers/technicians.
Job Duties
+ Provide project and technical leadership to cross functional teams including external partners for projects through conceptualization, development, product registration and commercialization
+ Establish and foster strong collaborative relationships with internal and external design/development partners, manufacturing partners and service providers. Provide critique and design guidance to ensure proper implementation and traceability of design outputs as compared to design inputs.
+ Work closely with Marketing in collection of user needs/feedback on product requirements and concepts
+ Lead the requirements development and management process, incorporating risk management elements as required.
+ Ensure compliance to product security and cyber security policies, and support efforts to author local SOP’s to ensure compliance.
+ Support the optimization of design control elements to comply with medical device regulations.
+ Implement product design with the intention of optimizing design for manufacturability and testability
+ Consider Cost of Goods and lifecycle when selecting components for device designs.
+ Develop engineering solutions, investigate competing technologies while considering the patent landscape, and protect engineering solutions by filing timely invention disclosures and working closely with the IPLegal team as needed
+ Establish and maintain detailed project plans, define risks and recommend contingency plans as required.
+ Provide support of Risk Management activities, working with Design Assurance
+ Lead all technical project execution activities and oversee the development of statistically sound design verification protocols/reports, design validation, and delivery system qualification activities
+ Lead the system safety certification process to standards such as EN60601-1, EN60601-1-2. Ensure software is developed in compliance to the methodologies of EN 62304.
+ Provide technical support to Marketing for technical brochures, training programs, and technical presentations to customers and the sales force
+ Maintain knowledge of technical product landscape, competitive products and procedural trends for target procedural areas
Job Qualifications
Required:
+ Bachelor’s degree in Engineering or the equivalent in years of industry experience.
+ Minimum years of related experience: 9 years with BS, 8 years with MS, or 5 years with PhD
+ Must have extensive working knowledge of, and experience in applying / developing, products in compliance with FDA and international requirements, including 820-CFR, ISO14971, IEC60601, GMP and other standards as they relate to the development and manufacture of medical devices.
+ Capable of developing all deliverables required to document the product design with appropriate specificity to enable high volume manufacturing with high quality.
+ Proficient in Microsoft Windows Office applications including MS Outlook, MS PowerPoint, MS Project, Visio, etc..
+ Solidworks working knowledge. Proficient in the creation and critical review of engineering drawings, tolerancing and tolerance analysis.
+ Knowledge of common manufacturing methodologies, technologies, and materials employed in medical devices.
+ Ability and experienced in approaching challenging and/or ambiguous engineering problems with scientific logic and problem solving skills. Ability to communicate complex technical concepts clearly and concisely is required.
Preferred:
+ Established track record of leading Medical Device development and/or sustaining engineering efforts utilizing a stage-gate process. Experience in hand held electro-mechanical devices is preferred.
+ Experience applying good judgement to make timely decisions as well as exhibit the ability to balance risk vs. benefits in a variety of situations.
+ Ability to effectively work within a requirements management system (e.g., JAMA, Doors) preferred.
+ Experience in the practical application of statistics and working knowledge of a statistical analysis package (Minitab).
+ Must be able to collaborate effectively with others, work well within cross-functional teams and across multiple sites, as applicable.Must be capable of effectively directing project teams on multiple work streams in parallel and leading teams towards accomplishment of objectives.Must be able to communicate effectively at all levels, both verbally and in writing. Strong presentation skills and the ability influence. Must have a positive attitude and capable of motivating teams / team members to accomplish efforts in a timely manner and with high quality.
Why join Olympus?
_We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture._
Equitable Offerings you can count on:
+ Competitive salaries, annual bonus and 401(k)* with company match
+ Comprehensive medical, dental, vision coverage effective on start date
+ 24/7 Employee Assistance Program
+ Free live and on-demand Wellbeing Programs
+ Generous Paid Vacation and Sick Time
+ Paid Parental Leave and Adoption Assistance*
+ 12 Paid Holidays
+ On-Site Child Daycare, Café, Fitness Center
Connected Culture you can embrace:
+ Work-life integrated culture that supports an employee centric mindset
+ Offers onsite, hybrid and field work environments
+ Paid volunteering and charitable donation/match programs
+ Diversity Equity & Inclusion Initiatives including Employee Resource Groups
+ Dedicated Training Resources and Learning & Development Programs
+ Paid Educational Assistance
*US Only
Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?
Learn more about our benefit and incentives (https://www.olympusamerica.com/careers/benefits-perks) .
The anticipated base pay range for this full-time position working at this location is $131,345.00 - $183,883.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.
At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .
Olympus is dedicated to building a diverse, inclusive and authentic workplace
We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.
Let’s realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Applicants with Disabilities:**
As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Research and Development
Source : Olympus Corporation of the Americas
