USA - New Jersey - Rahway, United States of America
Hybrid
Job Description
The Associate Principal Scientist, Drug/Device Combo Products will be responsible for leading and implementing medical device and combination product design controls 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 and design control principles 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 Responsibilities
Lead/contribute to device development, design controls for the assigned projects.
Lead the implementation and/or ensure effective execution of the device development strategy and design controls 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 and design controls approach within Device Development and with external suppliers.
Understand 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 processes, procedures, and tools.
Enhance our Company’s professional image and competitive advantage through publications, presentations, patents, and professional activities.
Stay current with relevant regulations, technologies, standards, and effectively share this knowledge with others.
Qualifications
Minimum requirements:
B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus 10 years of related experience
Has broad knowledge of medical device development, design controls and risk management
Led and managed development of DHF (design history file) deliverables for medical devices
Recognized as a subject matter expert in at least one medical device development or design controls area
Knowledge 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 evaluation
Self-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 skills
Willing to travel
Able to quickly pick up advanced domain knowledge
Able to multi-task continuously
Preferred requirements:
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 experience
Experience with the development drug-device combination product or a medical device component of a combination product
Experience with leading development projects at an enterprise level
Experience with device design, requirement management, FMEA, design verification, design validation, statistical sampling, and control strategy
Experience with regulatory fillings
Working knowledge of ISO 11608 and ISO 11040
Required Skills:
Accountability, Combination Products, Cross-Functional Teamwork, Design Controls, Design Failure Mode and Effect Analysis (DFMEA), Design Inputs, Design Specifications, Device Development, Injection Devices, Medical Device Quality Systems, Medical Devices, Medical Devices Design, Product Development, Project Management, Regulatory Submissions, Risk Management, Self Motivation, Stakeholder Communications, Systems EngineeringPreferred Skills:
Change Management, Design Verification Testing, LeadershipCurrent Employees apply HERE
Current Contingent Workers apply HERE
US 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.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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 Acts
The salary range for this role is
$142,400.00 - $224,100.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los 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 Ordinance
Search 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:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
06/4/2026*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.
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