Position: Specialist- DHF

Location: One resource for Brooklyn Park, Minnesota, USA

Three resources for Westborough, MA , US

Reports to: Team lead/project manager/program manager/associate manager

Position Summary:

An Onsite Coordinator is a lead who will be a coordinator and subject matter expert (SME) to work with the TEL internal cross-functional team and the Customer. The candidate should be familiar with Design Controls, Risk Management, and ISO 13485 requirements. Candidate should be able to produce system requirements, and V&V – activities and able to prepare documentation with the end goal of system qualification and product certification.

This role will engage with and mobilize the TEL internal team to create DHF documentation and resolve queries/gaps effectively, be responsible for coordination between customer SMEs and offshore team and collaborate on timely delivery and continuous improvement initiatives.

Responsibilities:

Experience – 7-9 years

· Single point of contact (SPOC) for both the offshore as well as the onsite team for assigned work streams

· Interacting directly with clients as well as an off-shore team regarding project requirements, deadlines, expectations, queries, and escalations

· Understand product specifications and accordingly make recommendations/ improvements for compliance with procedures (SOP), processes, and methodologies

· Expertise in Design Controls and processes, Risk Management, and ISO 13485 requirements. Experience working on system requirements, V&V – activities, and documentation.

· Develop Design Inputs documentation (VOC, URS, SRS), Validation Plan & Report, review relevant documents like User Requirement Traceability Matrix (URTM), User Requirement and Product Performance Specifications (URPPS), Product requirement Traceability Matrix(PRTM)

· Create / Update Design Verification and Design Validation documentation.

· Plan and Support verification testing, test methods, statistical analysis, and reporting

· Coordinate with Client’s technicians and attend the testing of medical devices and provide the required test results to the offshore team.

· Provide support on the design and development, 2D-3D CAD support, and drawings gap closure

· Update and maintain product risk management tools (i.e. Hazard Analysis, dFMEA)

· Good understanding of technical documentation as per EU-MDR, 21CFR 820.30

· Good Understanding of Packaging, labeling, sterilization, biocompatibility and medical device standards

· Should have effective mentorship quality to support and train team members with the necessary skills

· Drive the planning & tracking, if there are blockers, highlight/ escalate and bring resolution for the blockers

Keywords : DHF remediation, EUMDR, Verification and Validation, dFMEA, Risk Management, Traceability matrix, 21 CFR 820.30, ISO13485, ISO14971, IEC 60601, Medical Devices, CAPA, R&D Technical Documentation, Design control, Agile PLM, Minitab, Requirement Testing, Design History file

SKILLS AND QUALIFICATIONS:

• Bachelors (or higher) degree in engineering with a preference for Mechanical /Bio-Medical/Electro-Mechanical engineering
• Expertise in Medical device guidelines, standards, compliance to cGMP, GDP, Regulations, 21 CFR 820, ISO 13485, ISO 14971, IEC 60601-1, 60601-1-2
• Required knowledge of Risk Management / DFMEA / APQP / DFQ / Design Transfer/REACH RoHS
• Knowledge of risk assessment and control
• Experience with CAPAs and DHF remediation, EU-MDR technical documentation
• Experience with requirements specification and traceability
• Understand the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.
• Good CAD tools knowledge
• Experience working on Agile PLM, Minitab is a must.
• Working experience in MS Office (Word, Excel, PowerPoint, etc.)
• Good Written and Verbal Communication Skills
• leadership and problem-solving skills, detail-Oriented
• Strong analytical and interpersonal skills
• Proven ability to interface effectively with multiple levels of the organization and functional disciplines