Device Development Associate Principal Scientist (Associate Director Equivalent) – Development Strategy, Design Controls and Ris at Merck Sharp & Dohme (MSD)
Rahway, NJ 07065
About the Job
Job DescriptionPosition Description:Device Development Associate Principal Scientist – Development Strategy, Design Controls and Risk ManagementOur company’s Device Development (DD) Team designs, develops, and commercializes novel biologic/drug/vaccine - device enabled combination products to achieve safe and effective delivery to their intended site of action
The DD Team manages the development of the device constituent of our company’s pipeline of combination products across a variety of therapy areas and routes of administration including inhalation, implantation, and injection.This position will be responsible for leading and implementing medical device and combination product design controls and risk management activities for both new products and inline products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact with cross-functional development teams within and external to Device Development
The incumbent must be able to work well with all levels of employees and be able to effectively coordinate the execution of device development strategies
This individual will be expected to apply his/her knowledge of product development, design control principles and risk management techniques to positively support and influence clinical and commercial combination product development and launches to ensure they are developed and manufactured in accordance with regulatory, company, and customer requirements
Principal ResponsibilitiesLead/contribute to device development, design controls and risk management strategy for the assigned projects. Lead the implementation and/or ensure effective execution of the device development strategy, design controls and risk management activities for the assigned projects while adhering to management-approved strategic plans, corporate policies, and providing clear communication to cross-functional stakeholders, including external suppliers
Proactively resolve project obstacles and challenges and communicate device development strategy, design controls and risk management approaches within Device Development and with external suppliersUnderstand and apply regulatory / compliance requirements relative to design controls and risk management activities.Lead the preparation of materials for program presentations for management review and regulatory submission.Contribute to the development, implementation, and continuous improvement of design controls and risk management processes, procedures, and tools.Enhance our Company’s professional image and competitive advantage through publications, presentations, patents, and professional activitiesStay current with relevant regulations, technologies, standards, and effectively share this knowledge with othersPosition Qualifications:Education Minimum Requirement: B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus 10 years of related experienceRequired Experience and Skills: Has broad knowledge of medical device development, design controls and risk managementLed and managed development of DHF (design history file) deliverables for medical devicesRecognized as a subject matter expert in at least one medical device development or design controls and risk management areaKnowledge of U.S
and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, EN 62366, Council Directive 93/42/EEC, etc.Proven track record of applying analytical skills in product design, development, and evaluationSelf-motivated and work independently Proven ability to work with team members of diverse skill sets and backgrounds Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership Excellent communication, presentation, negotiation, project management, and organizational skillsWilling to travel Able to quickly pick up advanced domain knowledgeAble to multi-task continuouslyPreferred Experience and Skills:Master’s degree in one of the above disciplines plus 7 years related experience OR a PhD in one of the above disciplines plus 5 years related experienceExperience with the development drug-device combination product or a medical device component of a combination productExperience with leading development projects at an enterprise levelExperience with device design, requirement management, FMEA, design verification, design validation, statistical sampling, and control strategyExperience with regulatory fillingsWorking knowledge of ISO 11608 and ISO 11040NOTICEFORINTERNALAPPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package
To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.Current Employees apply HERECurrent Contingent Workers apply HEREUS and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities
Please click here if you need an accommodation during the application or hiring process.We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S
Equal Opportunity Employment laws, visit:EEOC Know Your RightsEEOC GINA SupplementPay Transparency NondiscriminationWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together
The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment
We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively
Learn more about your rights, including under California, Colorado and other US State ActsU.S
Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S
will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely
Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States
Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.Expected US salary range:$135,500.00 - $213,400.00Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days
A summary of benefits is listed here.San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring OrdinanceSearch Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities
All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company
No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place
Where agency agreements are in place, introductions are position specific
Please, no phone calls or emails. Employee Status: RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:25%Flexible Work Arrangements:HybridShift:1st - DayValid Driving License:NoHazardous Material(s):n/aJob Posting End Date:10/23/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date
Please ensure you apply to a job posting no later than the day BEFORE the job posting end date
SummaryLocation: USA - New Jersey - RahwayType: Full time
The DD Team manages the development of the device constituent of our company’s pipeline of combination products across a variety of therapy areas and routes of administration including inhalation, implantation, and injection.This position will be responsible for leading and implementing medical device and combination product design controls and risk management activities for both new products and inline products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact with cross-functional development teams within and external to Device Development
The incumbent must be able to work well with all levels of employees and be able to effectively coordinate the execution of device development strategies
This individual will be expected to apply his/her knowledge of product development, design control principles and risk management techniques to positively support and influence clinical and commercial combination product development and launches to ensure they are developed and manufactured in accordance with regulatory, company, and customer requirements
Principal ResponsibilitiesLead/contribute to device development, design controls and risk management strategy for the assigned projects. Lead the implementation and/or ensure effective execution of the device development strategy, design controls and risk management activities for the assigned projects while adhering to management-approved strategic plans, corporate policies, and providing clear communication to cross-functional stakeholders, including external suppliers
Proactively resolve project obstacles and challenges and communicate device development strategy, design controls and risk management approaches within Device Development and with external suppliersUnderstand and apply regulatory / compliance requirements relative to design controls and risk management activities.Lead the preparation of materials for program presentations for management review and regulatory submission.Contribute to the development, implementation, and continuous improvement of design controls and risk management processes, procedures, and tools.Enhance our Company’s professional image and competitive advantage through publications, presentations, patents, and professional activitiesStay current with relevant regulations, technologies, standards, and effectively share this knowledge with othersPosition Qualifications:Education Minimum Requirement: B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus 10 years of related experienceRequired Experience and Skills: Has broad knowledge of medical device development, design controls and risk managementLed and managed development of DHF (design history file) deliverables for medical devicesRecognized as a subject matter expert in at least one medical device development or design controls and risk management areaKnowledge of U.S
and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, EN 62366, Council Directive 93/42/EEC, etc.Proven track record of applying analytical skills in product design, development, and evaluationSelf-motivated and work independently Proven ability to work with team members of diverse skill sets and backgrounds Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership Excellent communication, presentation, negotiation, project management, and organizational skillsWilling to travel Able to quickly pick up advanced domain knowledgeAble to multi-task continuouslyPreferred Experience and Skills:Master’s degree in one of the above disciplines plus 7 years related experience OR a PhD in one of the above disciplines plus 5 years related experienceExperience with the development drug-device combination product or a medical device component of a combination productExperience with leading development projects at an enterprise levelExperience with device design, requirement management, FMEA, design verification, design validation, statistical sampling, and control strategyExperience with regulatory fillingsWorking knowledge of ISO 11608 and ISO 11040NOTICEFORINTERNALAPPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package
To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.Current Employees apply HERECurrent Contingent Workers apply HEREUS and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities
Please click here if you need an accommodation during the application or hiring process.We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S
Equal Opportunity Employment laws, visit:EEOC Know Your RightsEEOC GINA SupplementPay Transparency NondiscriminationWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together
The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment
We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively
Learn more about your rights, including under California, Colorado and other US State ActsU.S
Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S
will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely
Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States
Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.Expected US salary range:$135,500.00 - $213,400.00Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days
A summary of benefits is listed here.San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring OrdinanceSearch Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities
All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company
No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place
Where agency agreements are in place, introductions are position specific
Please, no phone calls or emails. Employee Status: RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:25%Flexible Work Arrangements:HybridShift:1st - DayValid Driving License:NoHazardous Material(s):n/aJob Posting End Date:10/23/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date
Please ensure you apply to a job posting no later than the day BEFORE the job posting end date
SummaryLocation: USA - New Jersey - RahwayType: Full time
