DEKA Research and Development Corporation

Product Complaints Engineer - Team Lead

DEKA Research and Development Corporation • $90K — $120K *
Manchester, NH 03103In-Person
Healthcare
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 4-year engineering degree in biomedical engineering or related field, or 2-year degree with significant experience
  • 3+ years in a cGMP environment handling complaint investigations, or 5+ years with a 2-year degree
  • Understanding of FDA Quality System requirements and Medical Device Reporting regulations
  • Familiarity with SalesForce software preferred
  • Excellent problem-solving, time management, and organizational capabilities

Responsibilities

  • Lead a team of Product Complaints Engineers on medical device issues
  • Review and evaluate product complaints for potential issues
  • Ensure compliance with Good Documentation Practices and QMS
  • Make informed decisions on medical device reporting
  • Collaborate with Third Party Manufacturers and regulatory agencies

Benefits

  • Dynamic work environment focused on innovative medical devices
  • High visibility role with direct impact on quality systems
  • Opportunities for professional growth and development
  • Collaborative team atmosphere
  • Engagement with diverse stakeholders including healthcare professionals and regulatory authorities
Full Job Description
DEKA R&D, on behlaf of Millyard Advanced Technologies, is looking for a Product Complaints Engineer - Team Lead to work in a dynamic Medical Device environment. The position reports to the Product Complaints Manager. This is a high visibility role with a significant direct impact in the Quality Management System.

How you will make an impact:
  • 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.
Skills needed to be successful:
  • 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.
  • 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.
  • Strong motivation to see individual tasks through to completion, and to help as needed to achieve team goals.
  • Exceptional time management skills with the ability to prioritize multiple projects and ensure compliance with regulations and standard operating procedures.
  • Good problem-solving and proficient computer skills are required.
  • 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.

About DEKA Research and Development Corporation

DEKA Research and Development Corporation is a research and development company based in Manchester, New Hampshire. The company was founded in 1982 by Dean Kamen, an inventor and entrepreneur who has over 440 patents to his name. DEKA is known for developing innovative technologies in a variety of fields, including medical devices, robotics, and transportation. Some of the company's most notable inventions include the Segway personal transporter, the iBOT mobility system, and the DEKA Arm prosthetic limb. DEKA has received numerous awards and accolades for its work, including the National Medal of Technology and Innovation in 2000.
Learn more about DEKA Research and Development Corporation
Size
1,000 employees
Industry
Aerospace & Defense
Founded
1982
* Ladders Estimates

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