Product Development Engineer - 158984

Atrium; New York (NY); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Fully covered medical insurance

Dental and vision insurance

401(k)

Paid time off

Job summary

A start-up biotech company in New York, NY is seeking a Product Development Engineer to bring products from lab concept to commercial manufacturing. The role involves leading product development activities, managing regulatory documentation, and supporting manufacturing readiness. Applicants should have at least 3 years of experience in the medical device field and a Bachelor's degree in Engineering or Life Sciences. Benefits include fully covered health insurance and a 401(k).

Qualifications

• 3+ years of experience in medical devices.
• Strong experience with design control.
• Direct experience moving medical device or biotech products to commercial production.

Responsibilities

• Lead product and process development activities.
• Build prototypes and refine designs using data-driven engineering.
• Manage risk analyses and controlled documentation.

Skills

3+ years of experience in medical devices

Strong experience with design control

Strong regulatory documentation experience

Excellent communication

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Our client is a start‑up biotech company that aims to improve lives through its research and products. They are looking to add a Product Development Engineer to their team.

Salary/Hourly Rate
$110k - $140k

Position Overview
The Product Development Engineer will work to bring products from lab concept to commercial manufacturing. This role supports prototyping, process development, and GMP readiness while working closely with R&D, Quality, Regulatory, and Operations teams.

Responsibilities Of The Product Development Engineer

• Lead product and process development activities that move technologies from laboratory testing to commercial scale.
• Build prototypes, run feasibility studies, and refine designs using data‑driven engineering.
• Manage risk analyses, verification/validation testing, and controlled documentation.
• Create and execute GLP/GMP qualification protocols and support tech transfer to manufacturing.
• Develop test methods, conduct characterization studies, and apply statistical tools (DOE, analysis, modeling).
• Partner with Quality and Supply Chain on supplier qualification and GMP material readiness.
• Support regulatory documentation, investigations, and updates to SOPs and technical files.

Required Experience/Skills for the Product Development Engineer

• 3+ years of experience in medical devices.
• Strong experience with design control.
• Direct experience moving medical device or biotech products from lab development to commercial production.
• Strong regulatory documentation experience and knowledge.
• Excellent communication, organization, and ability to manage multiple technical projects.

Preferred Experience/Skills for the Product Development Engineer

• Demonstrated success supporting commercialization or scale‑up activities.
• Hands‑on work in GLP/GMP labs or manufacturing environments.

Education Requirements

• Bachelor's degree in Engineering or Life Sciences is required.

Benefits

• Fully covered medical, dental, vision insurance, 401(k), paid time off, and more.

Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Engineering and Information Technology
Industries: Staffing and Recruiting

As a woman‑owned firm, we value diversity. We are an equal opportunity and affirmative action employer and will consider all applications without regard to race, sex (including gender, pregnancy, sexual orientation and gender identity), age, color, religion or creed, national origin or ancestry, veteran status, disability (physical or mental), genetic information, citizenship or any other characteristic protected by law. We will ensure that individuals with disabilities have reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Candidates who apply for roles through the Atrium website will be added to our candidate pool and may be considered for additional roles of a similar title. Please contact us to request an accommodation.

EOE/M/F/D/V/SO

Position ID: 158984