DEKA Research & Development · 1 week ago
Product Complaints Engineer - Team Lead
Manchester, NH
Full-time
Onsite
Mid, Senior Level
3+ years expDEKA Research & Development is seeking a Product Complaints Engineer - Team Lead to work in their Medical Device Research and Development environment. The role involves leading a team focused on product complaints, ensuring compliance with quality management systems and regulatory requirements, and collaborating with various stakeholders.
3D PrintingDeveloper PlatformManufacturingMedical Device
Responsibilities
Will lead a small team of Product Complaints Engineers focused on one or more of DEKA’s innovative, life-changing medical devices
Responsible for reviewing complaints related to potential device-related issues
Perform product complaint evaluations with minimal direction, utilizing experience and product knowledge
Ensure that complaint documentation follows Good Documentation Practices; meets QMS requirements; and complies with U.S. Food and Drug Administration (FDA) regulations / other regulatory requirements
Identify and make sound decisions regarding medical device reporting to regulatory agencies
Interface with Third Party Manufacturers, health care professionals, internal customers, and regulatory agencies
Participate in audits and CAPA investigations as they relate to complaint handling
Work with the forensic investigation team to align product investigations related to complaints
Track complaint processes to identify areas of improvement
Author procedures and work instructions
Establish and maintain a product training program
Contribute independently while also collaborating with other team members and departments
Maintain positive and cooperative communication with co-workers, customers, contractors, and vendors
Perform other related duties as assigned under management supervision
Qualification
Required
4-year engineering degree, preferably in biomedical engineering, and 3+ year(s) relevant experience in a cGMP environment supporting complaint handling investigations, medical device reporting, or product analysis; OR 2-year degree and 5+ year(s) relevant experience in a cGMP environment supporting complaint handling investigations, medical device reporting, or product analysis
Good problem-solving and proficient computer skills are required
Exceptional time management skills with the ability to prioritize multiple projects and ensure compliance with regulations and standard operating procedures
Solid written/verbal communication and organizational skills, as well as attention to detail
Sound technical writing skills
Ability to work well independently and on cross-functional teams in a fast-paced, changing environment
Preferred
Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred
Experience with SalesForce is preferred
Company
DEKA Research & Development
DEKA Research & Development provides technology solutions for power, mobility, and water applications along with fluid management.
501-1000 employees
H1B Sponsorship
DEKA Research & Development has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (13)
2023 (23)
2022 (16)
2021 (9)
2020 (7)
Funding
Current Stage
Late StageLeadership Team
C
Chris Langenfeld
Chief Engineer of Advanced R&D
Thomas Bollenbach
Project Manager
Recent News
2025-10-10
NH Business Review
2025-03-26
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