Associate Principal Engineer, Drug-Device Combination Products

About the role

This position is in our organization's Device Development & Technology (DD&T) group in our Research division. Our organization's DD&T group is responsible for the development of devices, combination products, processes, testing and assembly equipment from conception through product launch. Products include autoinjectors, inhalers, implants, infusion pumps, vaginal rings and connected devices/apps.

The person in this position contributes to high impact, complex, cross-functional, and cross-divisional teams, initiatives and will provide input to achieve project goals. Effective collaboration with teams is essential to meet our company's goals/objectives. The group also plays a key role in supporting commercially launched products.

Our company's DD&T Team is seeking a hands-on medical device product manufacturing and assembly engineer. This position will be responsible for hands-on factory floor work and collaboration, via interfacing with our company's internal sites, medical device suppliers and sub-suppliers.

This includes working with both small to large scale medical device assembly equipment suppliers, integrated manufacturing equipment component suppliers and purchased device component suppliers.

In addition, this position shall interrogate device supplier processes as they relate to our company's combination product process specifications and critical quality attributes to support our company's combination product quality control strategy and preserve essential performance requirements.

Education Minimum Requirement

• B.S. Degree in Mechanical Engineering or related field with a minimum 15 years of regulated industry experience

Required skills and key responsibilities for this position include

• Can develop detailed plans and strategies for combination of product assembly process and equipment development and lead technical team to deliver a qualified process and equipment for clinical or commercial use
• Author design/ process FMEA to capture design related risks and identify appropriate risk controls to ensure robust and efficient device functionality.
• Design and author Process validation activity and documentation like IQ, OQ, PPQ etc.
• Author protocols, reports, create drawings and specifications to ensure proper documentation of development activities in accordance with relevant SOPs.
• Experience in designing automated combination product assembly equipment and experience in managing equipment suppliers
• Experience in developing, implementing and troubleshooting combination product assembly equipment processes including vision systems, ultrasonic welding and automated component and glass feeding and handling systems
• Experience and the ability to manage all aspects of manufacturing site readiness including equipment qualification requirements and all associated documentation
• Understanding of device and combination product DFM/DFA principles and design and failure modes in relation to assembly processes
• Excellent oral and written communication skills and the ability to present complex information in a clear and concise manner to partner group stakeholders
• Mechanical aptitude and hands-on troubleshooting skills, with the ability to work independently in a laboratory setting and manufacturing floor setting.
• Strong interpersonal skills with an ability to collaborate in a team environment
• High level work ethic
• Support process and technology transfer to our company's manufacturing facilities

Preferred Experience and Skills

• CAD design, including knowledge of SOLIDWORKS and
• 3D printing and the ability to prototype and fabricate custom fixtures for assembly and testing

#EligibleforERP

Required Skills

Assembly Language (ASM), Assembly Language (ASM), Assembly Processes, CAPA Management, Combination Products, Component Development, Cultural Diversity, Design Controls, Design Failure Mode and Effect Analysis (DFMEA), Design for Assembly (DFA), Design for Manufacturing (DFM), Design Verification Testing, Device Design, Diversity Awareness, Documentation Preparation, Engineering Document Management, Engineering Support, Equipment Designing, Equipment Engineering, Fixtures Design, Human Factor Engineering, Manufacturing Strategies, Mechanical Testing, Medical Device Manufacturing, Medical Device Quality Systems {+ 9 more}

Preferred Skills

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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.
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• The primary location for this posting is: USA - New Jersey - Rahway

Pay and benefits

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is

$142,400.00 - $224,100.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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.

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

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: Not Indicated
• Valid Driving License: No
• Hazardous Material(s): n/a
• Job Posting End Date: 12/4/2026

Additional information

*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.