Sr. Engineer - Olympus Corporation of the Americas
Center Valley, PA
About the Job
Working Location: MASSACHUSETTS, WESTBOROUGH
Workplace Flexibility: Hybrid
Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.
Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.
Our Purpose is to make people’s lives healthier, safer, and more fulfilling.
Our Core Values are reflected in all we do: _Integrity – Empathy – Agility – Unity – Long-Term View_
We deliver on our purpose and our core values by staying True to Life.
Job Description
The Sr. R&D Engineer is responsible for assisting and/or leading the development of medical devices employed in various types of endoscopic surgeries. The primary responsibilities of this role include supporting all phases of device development, in particular the identification and evaluation of design options, the definition of product / performance specifications, and design verification and validation activities. Within a collaborative team environment, it will be expected that he or she will be a proactive communicator, collaborate well with others, manage their work efficiently, produce high quality work and consistently seek additional knowledge and skills. Creation of technical data, data analysis, and subsequent reporting will be an important aspect of this role, as well as helping to generate all documents / deliverables that will comprise the Design History File; therefore a working knowledge of FDA Design Controls is required.
May provide leadership and direction to Engineering Technicians.
Job Duties
+ Provides technical leadership, and/or significant contributions, to product development projects and/or technology development efforts.
+ Contributes to all aspects of product development activities and product Design History Files, such as; requirements creation/documentation, ideation / prototyping, design / development documentation, technical risk mitigation, verification testing and reports, design validation studies, risk management documentation, design reviews, and supports the compilation of documents to enable regulatory submissions.
+ Develops engineering solutions, investigates competing technologies, and collaborates with Olympus Patent Attorneys to secure a strong IP portfolio as needed.
+ Supports or leads efforts to evaluate and identify design solutions which will meet product/performance requirements, cost targets, and manufacturability requirements.
+ Develops product verification and validation testing requirements, authors testing protocols and reports to ensure products meet and/or exceed established specifications.
+ Employs statistical techniques to establish exceptional product quality, reliability, and robustness.
+ Supports in ensuring product and performance specifications are appropriate and accurate.
+ Supports internal and external suppliers and manufacturers as needed.
+ Including external design and/or development partners.
+ Supports marketing in the planning and creation of technical brochures, training programs, and technical presentations to customers and the sales force.
+ Supports engineering leadership as required.
+ All additional duties as directed.
Job Qualifications
Required:
+ Bachelor’s degree in engineering required.
+ Minimum 5 years of related experience with MS or 2 years with PhD. ·
Preferred:
+ Experience in Medical Device development and/or sustaining engineering efforts utilizing a stage-gate process.
+ Experience in hand held electro-mechanical devices is preferred.
+ Working knowledge of, and experience in applying, FDA Design Controls and international standards (e.g., Design Controls, 820-CFR, ISO14971, ISO10993, IEC60601, GMP, etc.).
+ Capable of developing many of the 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.
Why join Olympus?
_Here, people matter—our health, our happiness, and our lives._
+ Competitive salaries, annual bonus and 401(k)* with company match
+ Comprehensive Medical, Dental, Visions coverage effective on start date
+ 24/7 Employee Assistance Program
+ Free virtual live and on-demand wellness classes
+ Work-life balance supportive culture with hybrid and remote roles
+ 12 Paid Holidays
+ Educational Assistance
+ Parental Leave and Adoption Assistance
+ Volunteering and charitable donation match programs
+ Diversity & Inclusion Programs including Colleague Affinity Networks
+ On-Site Child Daycare, Café, Fitness Center
_*US Only_
_Limited locations_
We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks .
About us:
Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.
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) || Pennsylvania (US-PA) || Center Valley || Research and Development
Workplace Flexibility: Hybrid
Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.
Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.
Our Purpose is to make people’s lives healthier, safer, and more fulfilling.
Our Core Values are reflected in all we do: _Integrity – Empathy – Agility – Unity – Long-Term View_
We deliver on our purpose and our core values by staying True to Life.
Job Description
The Sr. R&D Engineer is responsible for assisting and/or leading the development of medical devices employed in various types of endoscopic surgeries. The primary responsibilities of this role include supporting all phases of device development, in particular the identification and evaluation of design options, the definition of product / performance specifications, and design verification and validation activities. Within a collaborative team environment, it will be expected that he or she will be a proactive communicator, collaborate well with others, manage their work efficiently, produce high quality work and consistently seek additional knowledge and skills. Creation of technical data, data analysis, and subsequent reporting will be an important aspect of this role, as well as helping to generate all documents / deliverables that will comprise the Design History File; therefore a working knowledge of FDA Design Controls is required.
May provide leadership and direction to Engineering Technicians.
Job Duties
+ Provides technical leadership, and/or significant contributions, to product development projects and/or technology development efforts.
+ Contributes to all aspects of product development activities and product Design History Files, such as; requirements creation/documentation, ideation / prototyping, design / development documentation, technical risk mitigation, verification testing and reports, design validation studies, risk management documentation, design reviews, and supports the compilation of documents to enable regulatory submissions.
+ Develops engineering solutions, investigates competing technologies, and collaborates with Olympus Patent Attorneys to secure a strong IP portfolio as needed.
+ Supports or leads efforts to evaluate and identify design solutions which will meet product/performance requirements, cost targets, and manufacturability requirements.
+ Develops product verification and validation testing requirements, authors testing protocols and reports to ensure products meet and/or exceed established specifications.
+ Employs statistical techniques to establish exceptional product quality, reliability, and robustness.
+ Supports in ensuring product and performance specifications are appropriate and accurate.
+ Supports internal and external suppliers and manufacturers as needed.
+ Including external design and/or development partners.
+ Supports marketing in the planning and creation of technical brochures, training programs, and technical presentations to customers and the sales force.
+ Supports engineering leadership as required.
+ All additional duties as directed.
Job Qualifications
Required:
+ Bachelor’s degree in engineering required.
+ Minimum 5 years of related experience with MS or 2 years with PhD. ·
Preferred:
+ Experience in Medical Device development and/or sustaining engineering efforts utilizing a stage-gate process.
+ Experience in hand held electro-mechanical devices is preferred.
+ Working knowledge of, and experience in applying, FDA Design Controls and international standards (e.g., Design Controls, 820-CFR, ISO14971, ISO10993, IEC60601, GMP, etc.).
+ Capable of developing many of the 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.
Why join Olympus?
_Here, people matter—our health, our happiness, and our lives._
+ Competitive salaries, annual bonus and 401(k)* with company match
+ Comprehensive Medical, Dental, Visions coverage effective on start date
+ 24/7 Employee Assistance Program
+ Free virtual live and on-demand wellness classes
+ Work-life balance supportive culture with hybrid and remote roles
+ 12 Paid Holidays
+ Educational Assistance
+ Parental Leave and Adoption Assistance
+ Volunteering and charitable donation match programs
+ Diversity & Inclusion Programs including Colleague Affinity Networks
+ On-Site Child Daycare, Café, Fitness Center
_*US Only_
_Limited locations_
We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks .
About us:
Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.
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) || Pennsylvania (US-PA) || Center Valley || Research and Development
Source : Olympus Corporation of the Americas
