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
- Risk Management (ISO 13485 & ISO 14971)
- Design History Files (DHF)
- Combination product development (drug delivery systems preferred)
- 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
- Risk Management & FMEA
- Regulatory Compliance
- Cross-functional Collaboration
- Technical Documentation
Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more. 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.