Sr. Design Quality Engineer, Contractor

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide The below client is with one of our client which is a leading global medical technology company. It offers a wide range of diagnostic imaging and laboratory diagnostics, as well as advanced therapies and digital health services. Its solutions span from prevention and early detection to diagnosis, treatment, and follow-up care, empowering healthcare providers worldwide.

Job Title: Sr. Design Quality Engineer, Contractor

Location: Newton, MA, 02466

Duration: 4+ Months

Job Type: Contract

Work Type: Onsite

Shift: 9.00 AM - 5.00 PM.

Job Description:

Responsibilities:

Represent the Quality Department as a subject matter expert in Design Control within cross-functional teams assisting in the development, review, and execution or approval of traceable design inputs/outputs.

Support design verification and validation activities by assisting in the development and review of test plans, protocols, and reports, including specific compliance testing (e.g., IEC-60601-1, ISO-10993-1, etc.)

Participate in the development of medical device software compliant with IEC-62304 and relevant regulations.

Lead risk assessment and ensure that risks are identified, analysed, and mitigated in accordance with ISO-14971 throughout the design process and compiled in the Risk Management File.

Lead the development FMEA (Use, Design, Software, Process) to systematically address potential failure mode

Support the development of the Usability Engineering File in accordance with IEC-62633 and applicable regulations.

Assist in the manufacturing transfer process including the creation and completion of planning documentation, DMR/DHR, and validation protocols (IQ, OQ, PQ).

Support other duties as assigned by manager. Required Knowledge/Skills, Education, and Experience

Bachelor's degree required in Engineering, Biomedical Engineering, or Life Sciences.

Minimum of 8 to 10 years of experience as a Quality or Design Quality Engineer in the medical device industry supporting the development of complex electro-mechanical devices is required.

Experience with new product development required.

Working knowledge of QSR, MDD/MDR, ISO-13485 and ISO-14971 is required.

Experience supporting the development of compliant medical device software or SaMD (i.e, IEC 62304/82304) and SWFMEA development is required.

Strong organizational skills, detail oriented, and the ability to meet changing deadlines on a fast-moving environment.

Ability to communicate effectively within a technical environment.

Team player who celebrates winning together

No travel required. Must-Have Skills:

Experience with New Product Development.

All required knowledge/skill on description. Here are some other experiences that are plus.

Design Quality Engineering

Validation Protocols

FMEA Risk analysis

Supplier qualifications

Mechanical, Electric experience Preferred Knowledge/Skills, Education, and Experience

Experience with single use consumable development and specific experience with ISO 10993-1 :2018, ISO 11607-1:2019, ISO 11135:2014 is preferred.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.