Associate Principal Scientist, Device Product and Process Development (Associate Director Equiv[...]

MSD; Rahway (NJ); Hybrid; USD 135,000 - 214,000; Full time

Job summary

An established industry player is looking for a skilled scientist to join their Device Product and Process Development Team. This role focuses on the technical interrogation and design of drug delivery devices, utilizing advanced analytical instruments and methods. You'll have the opportunity to identify risks and develop innovative solutions to enhance device performance. With a commitment to inclusion and diversity, this company offers a hybrid work model and a comprehensive benefits package, making it an exciting place to advance your career in a cutting-edge field.

Benefits

Bonus Eligibility

Health Care Benefits

Retirement Benefits

Paid Holidays

Vacation Days

Sick Days

Qualifications

• Ph.D. required with 4+ years in device design and engineering evaluation.
• Fluency in FEA and mechanical testing techniques is essential.

Responsibilities

• Conduct technical interrogation of drug delivery devices to identify risks.
• Design and develop functional improvements for device technology platforms.

Skills

Device Design

Structural Finite Element Analysis (FEA)

Mechanical Testing

3D CAD (Solidworks)

Design Failure Modes and Effect Analysis (FMEA)

Cross-functional Communication

Education

Ph.D. in Mechanical Engineering

Tools

X-ray Computed Tomography

Rheometry

Microscopy

Job description

Job Description

Our Company's Device Product and Process Development (DPPD) Team is seeking a hands-on device characterization and design focused scientist.

This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our pipeline to identify risks (i.e. when/how will the device fail?) and opportunities for improvement. They will utilize a wide variety of cutting-edge analytical instruments and methods, including in silico modeling, to build fundamental understanding of the devices’ material and functional properties and attributes. This understanding, combined with extensive data analysis/interpretation, will allow the role to design and develop functional improvements for these platforms and, as the opportunities arise, develop new and novel delivery technologies.

These drug delivery device technology platforms are often assemblages of glass pre-filled syringes, injection molded plastic components driving delivery of a drug, typically through mechanical or electro-mechanical means. Examples include, but are not limited to, injector pens and inhalers.

Education Requirement (minimum):

• Ph.D. in Mechanical Engineering or equivalent field is required.

Required Experience and Skills:

• A minimum of a Ph.D. plus 4 years of device design and engineering evaluation experience.
• Fluency in structural finite element analysis (FEA).
• Solid testing and troubleshooting skills able to work independently in a laboratory setting.
• Experience with mechanical testing, imaging, and measurement equipment and techniques, including, but not limited to, mechanical testing, surface characterization, x-ray computed tomography, rheometry, and microscopy.
• Experience in 3D CAD (e.g. Solidworks), geometric tolerancing and stack-up analysis.
• Fluency in Design Failure Modes and Effect Analysis (FMEA, DFMEA).
• Cross-functional communication – communicating complex mechanical engineering information in layman’s terms to facilitate cross-functional understanding and to support project timelines.
• Development experience in risk-oriented, regulated environments.
• Development project leadership with a proven track record collaborating with and managing external vendors/research partners.

Preferred Experience and Skills:

• Experience with medical device development with understanding of Design Controls (21 CFR 820.30).
• Familiarity with the following standards: Quality Management – ISO 13485, Risk Management – ISO 14971, EU MDR, ISO 11608 Needle-based injection system for medical use.
• Familiarity with Design Verification (DV) strategies and mechanical tests with validations, including engineering studies, design verification protocols, stability studies and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans. Ensures measurement systems analysis (MSA’s) for all finished product performance test methods as needed in tech transfer or lifecycle.
• Additional familiarity/experience with the following knowledge is a plus:
  • 21 CFR Part 4
  • 21 CFR 211
  • FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs & Biologics
  • ISO 13485
  • ISO 14971
  • ISO 11040
  • ISO 10993

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.

U.S. Hybrid Work Model

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, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.

Expected US salary range:

$135,500.00 - $213,400.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.

Employee Status: Regular

Relocation: Domestic

VISA Sponsorship: Yes

Travel Requirements: 10%

Flexible Work Arrangements: Hybrid

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): n/a

Job Posting End Date: 04/18/2025

*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.