Quality Engineer
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.
Desirable Qualifications
Auditor certificate for ISO 13485 and/or AS9100 desired.
Experience working on medical electromechanical 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.
To apply, please send your resume, cover letter, and portfolio to Don Baumgarten at careers@productcreationstudio.com and include “Resume for Quality Engineer” in the subject line.
About Product Creation Studio:
Product Creation Studio is an integrated product development consultancy. We fuse our passion and expertise in strategic design and precision engineering to create, innovate, and solve complex challenges for our clients across the consumer, medical, and industrial fields. From burgeoning start-ups to top-tiered companies, we make products happen.
Our office is located in beautiful downtown Seattle, right next to Lake Union. We offer a competitive benefits package including medical/dental/vision, FSA, and 401k, in addition to a creative, friendly work environment.
Our company is committed to equal opportunity employment. We do not discriminate against employees or applicants on any basis including, but not limited to: veteran status, uniform service member status, race, color, religion, sex, national origin, physical or mental disability, genetic information, or any other protected class under federal, state, or local law.