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Job Description

We are seeking a highly motivated individual for the role of Associate Director Engineering - MDCP Technical Lead, supporting the Wilson Packaging Technical Operations Team. This role will serve as the primary medical device and combination product (MDCP) point of contact for the site Packaging Technical Operations team. The MDCP Technical Lead will have responsibilities for supporting the design/tech transfer and sustainment activities of MDCPs at the Wilson site and ownership for various MDCP-related QMS topics to ensure compliant implementation and robust application at the site. Experience in design controls, device risk management, medical device, combination products, prefilled syringes, autoinjectors, process validation, automation, packaging process, equipment and components, equipment qualification and related regulatory requirements are a must for this position. The ability to apply these in a fast-paced operating environment to resolve issues and meet customer needs in a compliant manner are at the core of this position. The Associate Director will routinely face competing priorities, and must manage time effectively, while keeping stakeholders and team members informed with effective communication.

This individual is expected to function as an independent contributor or lead a small team of engineers, while supporting global or site-specific projects and commercial operations. The role includes leading, enabling or consulting in the development and execution of strategic plans for new product introductions, new or changes to device assembly and packaging assets (including change control and validation/qualification strategies), problem-solving, and continuous improvement, by working with internal and external partners. This role will work closely with the Wilson site QA and Operations MDCP Leads, Device Development and Technology Lead, PTO Engineers, and our Product Development and Commercialization groups, among others.

Key Functions

+ Understand the big picture, and how activities link to our Company strategy and business goals

+ Utilize device risk management tools to build and maintain device or combination product risk management programs in development and life cycle management.

+ Lead or support all risk management efforts for introduction or changes impacting MDCPs at the site. Work closely with internal and external stakeholders to develop and execute a comprehensive risk management strategy that integrates defined control measures, considering patient safety and product quality.

+ Lead technical investigations of medical device and combination product for commercial products

+ Work with PTO Engineers, Device Development and Commercialization teams on developing validation strategies for new or changes impacting MDCPs, in alignment with Company and regulatory guidelines.

+ Facilitate design and technology transfer of medical device and combination products from development to commercialization.

+ Provide support for completion of regulatory filing sections, and support response to questions and pre-approval inspections from a device assembly and packaging process standpoint.

+ Own and maintain in good compliance health QMS technical topics related to MDCP such as design controls, tech/design transfer, process validation, etc.

+ Support regulatory inspections and maintain proficiency in ISO 13485 and other relevant quality management systems

+ Demonstrate the necessary inclusion skills to integrate inputs and perspectives from various sources, and communicate the decision to team members, key stakeholders and sponsors

+ Solicit feedback to ensure that customer/stakeholder needs are the cornerstone of decisions and expectations

+ Ensure that all activities are conducted with the highest regard for safety, quality, and regulatory compliance, aligning with the company's divisional and local site procedures.

Education

+ Required | BS degree or higher in Engineering or related field

+ Preferred | BS or higher in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Materials Engineering, or similar

Experience | Skills | Knowledge

Required

+ Eight (8) years of relevant combined experience in medical device and combination products and packaging

+ Demonstrated technical leadership in medical device and combination product manufacturing, assembly and packaging sites and functional areas

+ Experience with medical device or combination product commercialization, operations support, and materials/components

+ Experience with autoinjectors or other complex drug-delivery systems and associated pre-filled syringe systems or cartridges.

+ Experience with device assembly and packaging equipment/processes

+ Experience in deviation management, change control, process scale up, process validation, equipment qualification, and the fundamentals of Quality Management system documentation structure/systems

+ Proficiency in project management

+ Principled verbal and written communications

Preferred

+ Eight plus years in medical device, pharmaceutical or in biotech organizations

+ Eight plus years in design control, risk analysis and change control management for medical device or combination products

+ Experience in design controls, ISO 13485, risk management/ISO 14971-2019

+ Experience with design verification testing

+ Experience in supporting regulatory inspections.

+ Experience in commercialization of high-volume medical device or combination products

+ Experience with injection molding and working with medical device suppliers

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) 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:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

Effective 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”.

**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:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Change Management, Change Management, Combination Products, Compliance Packaging, Cross-Functional Teamwork, Deviation Management, Engineering Standards, Good Manufacturing Practices (GMP), Injection Moldings, Management Process, Manufacturing Scale-Up, Mechanical Engineering, Medical Device Management, Medical Devices, Packaging Engineering, Packaging Processes, Plastic Injection Moulding, Problem Solving, Process Optimization, Product Risk Management, Quality Management, Regulatory Compliance, Regulatory Inspections, Risk Analysis, Risk Management {+ 1 more}

Preferred Skills:

Job Posting End Date:

06/4/2025

*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.

**Requisition ID:** R350407