Device Development Associate Principal Scientist (Associate Director Equivalent) - Development Strategy, Design Controls and Risk Management

$135,500 - $213,400/Yr

Merck KGaA Darmstadt Germany - Rahway, NJ

Full-time - Senior

Onsite - Rahway, NJ

Chemical Manufacturing

About the position

The Device Development Associate Principal Scientist will lead and implement design controls and risk management activities for medical devices and combination products. This role involves overseeing the development process from early design concepts through commercialization, ensuring compliance with regulatory requirements and effective communication with cross-functional teams.

Responsibilities

• Lead/contribute to device development, design controls and risk management strategy for assigned projects.
• Ensure effective execution of device development strategy, design controls, and risk management activities while adhering to corporate policies.
• Proactively resolve project obstacles and communicate strategies within Device Development and with external suppliers.
• Understand and apply regulatory/compliance requirements related to design controls and risk management activities.
• Prepare materials for program presentations for management review and regulatory submission.
• Contribute to the development and continuous improvement of design controls and risk management processes, procedures, and tools.
• Enhance the company's professional image through publications, presentations, patents, and professional activities.
• Stay current with relevant regulations, technologies, and standards.

Requirements

• B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or related field plus 10 years of related experience.
• Broad knowledge of medical device development, design controls, and risk management.
• Experience managing development of DHF (design history file) deliverables for medical devices.
• Recognized subject matter expert in at least one medical device development or design controls area.
• Knowledge of U.S. and global medical device regulations, including FDA combination products, cGMP, and ISO standards.
• Proven analytical skills in product design, development, and evaluation.
• Self-motivated with the ability to work independently and in teams.
• Strong interpersonal skills and strategic thinking ability.
• Excellent communication, presentation, negotiation, project management, and organizational skills.

Nice-to-haves

• Master's degree in relevant discipline plus 7 years related experience or PhD plus 5 years related experience.
• Experience with drug-device combination product development.
• Experience leading development projects at an enterprise level.
• Familiarity with device design, requirement management, FMEA, design verification, and validation.
• Experience with regulatory filings.
• Working knowledge of ISO 11608 and ISO 11040.

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