Associate Principal Scientist, Device Product and Process Development

$135,500 - $213,400/Yr

Merck & Co. - Rahway, NJ

Full-time - Senior

Onsite - Rahway, NJ

Chemical Manufacturing

About the position

The Device Product and Process Development (DPPD) Team is seeking a hands-on scientist focused on device characterization and design. This role involves the technical interrogation of drug delivery device technology platforms to identify risks and opportunities for improvement. The scientist will utilize advanced analytical instruments and methods, including in silico modeling, to understand the devices' material and functional properties, leading to the design and development of functional improvements and novel delivery technologies.

Responsibilities

• Conduct technical interrogation of drug delivery device technology platforms to identify risks and opportunities for improvement.
• Utilize cutting-edge analytical instruments and methods, including in silico modeling, to build understanding of devices' material and functional properties.
• Perform extensive data analysis and interpretation to inform design improvements for drug delivery devices.
• Develop new and novel delivery technologies as opportunities arise.
• Collaborate with cross-functional teams to communicate complex mechanical engineering information effectively.

Requirements

• Ph.D. in Mechanical Engineering or equivalent field.
• Minimum of 4 years of device design and engineering evaluation experience.
• Fluency in structural finite element analysis (FEA).
• Solid testing and troubleshooting skills in a laboratory setting.
• Experience with mechanical testing, imaging, and measurement equipment and techniques.
• Proficiency in 3D CAD (e.g. Solidworks), geometric tolerancing, and stack-up analysis.
• Fluency in Design Failure Modes and Effect Analysis (FMEA, DFMEA).
• Development experience in risk-oriented, regulated environments.
• Proven track record in development project leadership and collaboration with external vendors/research partners.

Nice-to-haves

• Experience with medical device development and understanding of Design Controls (21 CFR 820.30).
• Familiarity with Quality Management - ISO 13485, Risk Management - ISO 14971, EU MDR, ISO 11608 standards.
• Experience with Design Verification (DV) strategies and mechanical tests with validations.
• Familiarity with measurement systems analysis (MSA's) for finished product performance test methods.

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits for employee and family
• Retirement benefits
• Paid holidays
• Vacation
• Sick days