Senior Product Development Engineer – Medical Devices

Dexian; Boston (MA); On-site; USD 96,432 - 107,452; Full time

Job summary

Dexian is looking for a Senior Engineer – Design & Risk Management for Combination Products in Boston, MA or Providence, RI. This role focuses on medical device design controls and risk management, collaborating with cross-functional teams. The ideal candidate will have 5–10 years of experience in regulated environments and strong technical writing skills. The position is a 6-month contract with competitive pay and possibly extends to a full-time role.

Qualifications

• 5–10+ years of experience in a regulated medical device environment.
• Hands-on experience with Design Controls and Design History Files (DHF).
• Strong knowledge of FDA regulations, EU MDR, and 21 CFR Part 820.

Responsibilities

• Author and maintain design documentation for combination products.
• Compile and manage Design History Files (DHF) ensuring regulatory compliance.
• Perform and document risk assessments (DFMEA, PFMEA, UFMEA).

Skills

Design Control & Product Development

Regulatory Compliance

Cross-functional Collaboration

Technical Documentation

Education

B.S. or M.S. in Engineering or related discipline

Tools

Jama

Windchill

Job description

Job Title: Senior Engineer – Design & Risk Management (Combination Products)

Location: Boston, MA or Providence, RI

Pay Range : $70/hr - $78/hr on w2

Duration: 6 Month Contract with Possibility of Extension and Conversion

Overview

• We are seeking an experienced professional with strong expertise in medical device design controls and risk management for drug-device and biologic-device combination products.
• This role will support the design, development, and lifecycle management of innovative therapies in a highly regulated environment.

Key Responsibilities

• Author and maintain design documentation for combination products
• Compile and manage Design History Files (DHF) ensuring regulatory compliance
• Apply design controls aligned with FDA, EU MDR, and internal quality systems
• Perform and document risk assessments (DFMEA, PFMEA, UFMEA)
• Translate user needs into functional requirements (Human Factors Engineering)
• Support product development activities including specifications, packaging, and verification
• Collaborate cross-functionally with Quality, Regulatory, Clinical, Manufacturing, and Process Development teams
• Assist in technology transfer from development to clinical/commercial manufacturing
• Utilize requirements management tools (e.g., Jama, Windchill)

Required Qualifications

• B.S. or M.S. in Engineering or related discipline
• 5–10+ years of experience in a regulated medical device environment
• Hands-on experience with:
  • Design Controls
  • Design History Files (DHF)
  • Strong knowledge of FDA regulations, EU MDR, and 21 CFR Part 820
  • Experience with cGxP principles
  • Strong technical writing and documentation skills

Preferred Qualifications

• Experience with Jama, Windchill, or similar requirements management tools
• Ability to provide real-world examples of applying ISO 13485 and ISO 14971
• Experience supporting human factors engineering and usability studies

Key Skills

• Design Control & Product Development
• Regulatory Compliance
• Cross-functional Collaboration
• Technical Documentation

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.