Associate Principal Engineer, Drug-Device Combination Products

HireLifeScience; Rahway (NJ); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical Benefits

Dental Benefits

Vision Benefits

401(k) Plan

Paid Holidays

Job summary

HireLifeScience seeks a hands-on device manufacturing and assembly engineer within the DD&T group to drive development of automated assembly equipment and processes for combination products from concept through qualification and readiness for clinical or commercial use.

Qualifications

• B.S. Degree in Mechanical Engineering or related field with a minimum 15 years of regulated industry experience.
• Develop detailed plans and strategies for 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

Responsibilities

• Lead technical teams to deliver a qualified assembly process and equipment for clinical or commercial use.
• Author, review and implement design controls and risk analyses including FMEA to ensure robust device functionality.
• Develop and validate processes (IQ/OQ/PPQ) and document all development activities per SOPs.
• Manage equipment suppliers and coordinate with internal sites and external vendors.
• Design automated assembly equipment and integrate vision systems, welding, and feeding/handling processes.
• Oversee site readiness, equipment qualification, and associated documentation for manufacturing deployment.
• Communicate complex technical information effectively to stakeholders and cross-functional teams.
• Troubleshoot mechanical and process issues on the factory floor and provide hands-on support.

Skills

DFMEA

DFA

DFM

Design Controls

CAPA Management

Combination Products

Device Design

Mechanical Testing

Human Factor Engineering

Equipment Design

Education

B.S. Degree in Mechanical Engineering

Tools

SOLIDWORKS

3D Printing

Job description

Job Description

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

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}

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.

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

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.

The salary range for this role is

$142,400.00 - $224,100.00

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 https://jobs.merck.com/us/en/compensation-and-benefits .

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

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:

10/13/2026

*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:

R418201