Associate Principal Scientist/Engineer, Medical Device and Combination Products, ISO/DV Testing Manager

MSD Malaysia

West Point (PA)

On-site

USD 142,000 - 224,000

Full time

4 days ago

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Benefits offered by this job

Medical insurance

Retirement benefits (401k)

Paid holidays

Vacation

Sick days

Job summary

CPDA at West Point, PA is seeking an Associate Principal Scientist/Engineer to lead design verification testing for MDCPs, manage method development and ensure GMP/ISO compliance. The role combines strategic oversight with hands-on technical leadership across internal and external labs.

The ideal candidate will have an advanced engineering degree, 3–6+ years in analytical testing within regulated labs, and experience with device validation, Design Controls, and regulatory standards.

Qualifications

BS, MS or PhD in Mechanical, Chemical or Biomedical Engineering or associated scientific discipline, such as Chemistry.
3 years with PhD or 6 years with BS or MS in analytic testing in an industry role.
Experience in a cGMP or ISO 13485 certified analytical laboratory; knowledge of GMP/GDP.

Responsibilities

Strategic and day-to-day management of design verification testing to support commercial products.
Technical oversight of method development, validation and implementation in internal/external labs.
Ensuring safety, environmental, cGMP and ISO 13485 compliance for all lab activities.
Collaboration to drive test method development, validation and instrumentation upgrades.
Overseeing CPDA analysts in ISO laboratory and providing coaching.

Skills

Analytical Development

Analytical Testing

GMP Laboratory

GMP Testing

Interdisciplinary Collaboration

Mechanical Testing

Medical Device Management

Medical Devices

Medical Device Technologies

Medical Device Testing

Synthetic Chemistry

Test Procedure Development

Education

Engineering degree (BS/MS/PhD)

Job description

Center for Packaging & Device Analytics (CPDA) – Associate Principal Scientist/Engineer

Within our Manufacturing Division, the Center for Packaging & Device Analytics (CPDA) has responsibility for applied physical, material & analytical science to support production and commercialization of product packaging and drug-delivery medical device/combination-products (MDCPs), such as auto-injectors and pre-filled syringes. We are an interdisciplinary engineering science Center of Excellence that supports the entire global human-health portfolio and partners closely with various Packaging or Device Technology engineering groups, assembly/packaging sites, and partner analytical groups.

The CPDA is located at our company's large research and manufacturing site at West Point, PA, where our packaging & device laboratories are established. The CPDA is seeking an Associate Principal Scientist/Engineer for an exciting opportunity to manage and oversee formal MDCP method validation/transfer and design verification testing activities in our dedicated ISO design verification laboratory [internal] and partner contract laboratories [external].

Responsibilities

(1) strategic and tactical (day-to-day) management of design verification testing to support our commercial products to meet critical project timelines
(2) technical oversight of method development, validation, and implementation of analytical methods and associated investigational support at both internal and external laboratories
(3) ensuring safety, environmental and cGMP and ISO 13485 compliance for all laboratory activities and operations
(4) collaborating with CPDA program leads to drive test method development, validation and implementation of new instrumentation/analytical technologies for the laboratory to support current and future commercial MDCP DV testing
(5) oversight and technical coaching of CPDA analysts in the ISO laboratory

Required Education

BS, MS or PhD in Mechanical, Chemical or Biomedical Engineering or associated scientific discipline, such as Chemistry.

Required Experience

A minimum of 3 years with PhD, or 6 years with BS or MS, in an industry role centered on analytical testing.
Successful work within a cGMP or ISO 13485 certified analytical laboratory.
Strong knowledge and experience with regulatory compliance principles [Good Manufacturing Practices (GMPs), Good Documentation Practices (GDPs)] and quality assurance practices related to analytical testing.

Preferred Experience & Skills

Demonstrated competency with mechanical testing.
Successful manager / supervisor of staff within a cGMP or ISO 13485 certified analytical laboratory.
Expertise with medical device development and understanding/familiarity of Design Controls (21 CFR 820.30), ISO 13485, cGMP, and relevant industry standards.
Hands‑on experience in MDCP method development, Device Characterization, and Design Verification (DV) for development, engineering studies, design verification, stability studies and/or validation—including analytical strategy and protocol design.
Advanced expertise with mechanical functionality and strength testing, container closure integrity testing and dimensioning—such as (not limited to) tensile/compression/torsional testing, optical or x-ray microscopy, optical comparator methods, dye ingress testing, etc.

Required Skills

Analytical Development
Analytical Testing
GMP Laboratory
GMP Testing
Interdisciplinary Collaboration
Mechanical Testing
Medical Device Management
Medical Devices
Medical Device Technologies
Medical Device Testing
Synthetic Chemistry
Test Procedure Development

Preferred Skills

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

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.

Salaries and Benefits

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.

Benefits

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days
More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Employment Conditions