Sr. Product Development Engineer

Katalyst HealthCares and Life Sciences

• $100K — $130K *
Boston, MA 02115In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
More than 3 months ago
Job Overview by Ladders

Qualifications

  • B.S. or M.S. in Engineering or related discipline
  • 5-10 years of experience in regulated medical device or combination product environment
  • Experience with drug delivery systems and combination products
  • Strong knowledge of design controls and product lifecycle processes
  • Proficient in risk management per ISO 14971
  • Familiarity with FDA regulations, EU MDR, ISO 13485, and 21 CFR Part 820
  • Excellent technical writing and organizational skills
  • Proficiency in JAMA and Windchill software

Responsibilities

  • Author and maintain design control documentation for drug-device and biologic products
  • Ensure compliance with FDA, EU MDR, and internal quality standards
  • Support product development from early phases to commercial manufacturing
  • Translate user needs into functional requirements and design outputs
  • Develop design outputs, specifications, packaging, and verification activities
  • Perform risk management activities including DFMEA, UFMEA, and PFMEA
  • Contribute to quality systems and risk management processes
Full Job Description
Roles & Responsibilities :
  • uthor and maintain design control documentation for combination drug-device and biologic products, including Design History Files (DHF).
  • Ensure compliance with FDA, EU MDR, and internal quality standards throughout the product lifecycle.
  • Support product development and technology transfer from early development through clinical and commercial manufacturing.
  • Translate user needs into functional requirements and design outputs, including support of Human Factors Engineering activities.
  • Develop and support design outputs, specifications, packaging, and verification activities.
  • Perform risk management activities, including authoring DFMEA, UFMEA, and PFMEA.
  • Contribute to requirements management, quality systems, and risk management tools/processes to support development activities.

Requirements:
  • B.S. or M.S. in Engineering or related discipline.
  • 5-10 years of experience in a regulated medical device or combination product environment.
  • Experience with combination products, preferably strong drug delivery systems experience.
  • Strong knowledge of design controls, DHF management, and product lifecycle processes.
  • Experience with risk management in accordance with ISO 14971.
  • Familiarity with FDA regulations, EU MDR, ISO 13485, and 21 CFR Part 820.
  • Strong technical writing, communication, and organizational skills.
  • Experience JAMA and Windchill software
  • bility to work independently and manage multiple projects in a fast-paced environment.
* Ladders Estimates

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