Job Description

Our Company is seeking an experienced Associate Director to lead Laboratory Operations, Logistics, and Safety Compliance supporting our device and combination product development laboratories. This role is critical in enabling safe, compliant, and efficient laboratory environments that accelerate the development of innovative medicines and medical devices for patients worldwide.

The successful candidate will bring strong prior experience in device-focused laboratory environments performing development and fit-for-purpose activities for clinical supply, including engineering labs, testing labs, and human factors/usability spaces, along with deep expertise in EHS and inspection readiness.

Laboratory Operations Leadership

• Provide strategic and operational leadership for laboratories supporting medical device and combination product development.

• Oversee lab operations, ensuring high standards for efficiency, reliability, and compliance.

• Manage equipment lifecycle processes, including qualification, calibration, maintenance, and decommissioning.

Safety & Environmental Health (EHS) Compliance

• Ensure compliance with OSHA regulations, corporate EHS standards, and global safety requirements.

• Lead safety programs addressing device-specific hazards (e.g., mechanical systems, electrical testing, prototyping equipment, usability testing).

• Drive proactive risk assessments, incident investigations, and CAPA implementation.

Device & Combination Product Support

• Partner with R&D and engineering teams to support design verification and validation (DV/V), human factors studies, and device testing activities.

• Ensure laboratory environments meet requirements for regulated device development and testing.

• Support regulatory inspections and audits (e.g., FDA, notified bodies) for device and combination product programs.

Facilities & Infrastructure Oversight

• Collaborate with Facilities and Engineering to maintain compliant laboratory infrastructure, including specialized device labs and test environments.

• Ensure appropriate layout, safety controls, and environmental conditions are in place to support device development workflows.

Cross-Functional Collaboration

• Serve as a key interface with Quality, Regulatory Affairs, Engineering, and EHS organizations.

• Contribute to inspection readiness efforts and represent laboratory operations during audits and governance reviews.

People Leadership

• Lead, coach, and develop a team responsible for lab operations and safety.

• Foster a strong culture of safety, accountability, and continuous improvement across lab users.

• Bachelor’s degree in Engineering, Life Sciences, or related discipline (advanced degree preferred).

• Minimum 8+ years of relevant industry experience, including substantial experience in:

  • Medical device or drug-device combination product environments

  • Laboratory operations, technical operations, or facilities leadership

  • EHS and regulatory compliance within laboratory settings

• Demonstrated hands-on experience supporting device testing, prototyping, or engineering labs.

• Strong knowledge of:

  • FDA Quality System Regulation (21 CFR Part 820)

  • ISO 13485 and applicable device standards

  • OSHA/EHS requirements for laboratory and engineering environments

• Experience supporting combination product (drug-device) development programs.
  
• Familiarity with human factors/usability laboratory environments.
  

• Professional certification in EHS, safety engineering, or quality systems.

• Demonstrated ability to drive operational excellence and continuous improvement initiatives.

• Strategic thinking and decision-making

• Strong collaboration and stakeholder management

• Commitment to safety, quality, and compliance

• Ability to influence across a matrixed organization

• Results-driven with a focus on patient impact

#eligibleforERP

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Required Skills:

Preferred Skills:

Current Employees apply

Current Contingent Workers apply

US and Puerto Rico Residents Only:

The salary range for this role is

This 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 .

You can apply for this role through (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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.