Do you want to... Fulfill why you got into engineering? Work on products that make a difference? Find a dynamic work environment where you can shape the future of products?

Product Creation Studio is looking for a highly qualified quality engineer to own and drive our quality system forward. As a quality engineer you will assume ownership of all quality engineering project tasks and deliverables, and manage the Hardware and Software verification process for our client projects. You must be able to integrate with the team, working in tandem with design and all engineering disciplines, and be an engineering leader.

Basic Qualifications:

Bachelor of Science degree in Engineering (ME, EE, SW), Computer Science or related equivalent experience and/or education.
Experience in quality engineering tasks associated with product development of medical devices, or five years equivalent related experience.
Working knowledge of 21 CFR 820 (Quality System Regulation for Medical Devices), ISO 13485 (Quality Management Systems – Requirements for Regulatory Purposes), and ISO 14971 (Medical Devices – Application of Risk Management to Medical Devices).
Working knowledge of IEC 60601-1 (Medical Electrical Equipment), IEC 61010-1 (Safety Requirements for electrical equipment for measurement, control and laboratory use) and IEC 62304 (Medical Device Software – Software Life Cycle Processes).
Ability to plan and execute quality engineering activities that comply with regulatory requirements and industry best practices.
Proficient in developing requirement specifications at both system and design levels.
Proficient in developing verification test plans, protocols, and verification summary reports.
Proficient in the training of personnel assigned to generate or execute verification test protocols.
Proficient in developing risk management plans, performing risk/hazard analysis, fault tree analysis, and failure modes and effects analysis.
Ability to work effectively in a cross-functional team environment and strong analytical ability with active listening skills.
Ability to interpret and articulate FDA and other regulatory requirements for medical devices.
Excellent verbal and written communication skills and interpersonal skills, with the ability to work effectively with individuals and groups at all organization levels.
Auditor certificate for ISO 13485 and/or AS9100 desired.
Experience working on medical electro-mechanical devices, embedded software development, and/or testing where product safety is paramount (avionics electro-mechanical device experience is also acceptable).
Ability to provide accurate estimates for quality engineering tasks.

Desirable Qualifications

Audit or certificate for ISO 13485 and/or AS9100 desired.

Experience working on medical electro-mechanical devices, embedded software development, and/or testing where product safety is paramount (avionics electro-mechanical device experience is also acceptable).

Ability to provide accurate estimates for quality engineering tasks.

Product Creation Studio

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