Senior Engineer, Design Assurance

Valencia, CA – Hybrid (3 days/week on site, 2 days remote)
Senior Engineer, Design Assurance  The Senior Design Assurance Engineer is responsible for compliance to procedures and regulations for Design Control of Software, Firmware and Hardware associated with Cochlear Implant Technology. Works collaboratively as the DA representative within a multidisciplinary product development team to ensure the design intent of products is realized effectively and efficiently, including compliance with 21

CFR
820, ISO
13485, ISO 14971, IEC 60601, MDSAP and MDR.  Responsibilities:
Manages all Design Assurance aspects of multiple related projects to ensure the overall program is aligned to and directly supports the achievement of strategic objectives (schedule, budget, quality, resources)
Leads simulation of design concepts under expected and worst case use conditions Communicates project progress, risks, issues and mitigations across and up the organization

Identifies, interprets and provides expertise to the organization on the implementation of international standards (ISO 14971, IEC 60601-1, ISO 13485, particular standards, etc.) Ensures designs can meet product specifications, regulatory requirements, and international safety standards such as IEC 60601-1

Responsible for testing strategy and execution, including feasibility, DV&V, human factors, usability engineering etc.

Identifies and leads process improvements to ensure consistent implementation of internal requirements and external regulations and standards.

As needed, participates in or leads the investigations and analysis of product changes and CAPA’s.Prepares documentation for and support regulatory submissions (USA, EU, International)
Creates and delivers training to ensure compliance of medical devices per international standards

Mentors, trains and otherwise provides guidance to newer or less experienced team members, leveraging product skills and experience More about you:
Bachelor’s degree in Engineering or a related technical discipline required, with training in Design for Manufacturability, Design for Six Sigma, and Lean principles; graduate degree in Engineering, ASQ certification, or related advanced technical education preferred. Minimum 8 years of product development and/or design assurance experience, including at least 5 years supporting Class III medical devices, with demonstrated success applying Quality Management principles throughout the product lifecycle and hands-on engineering testing experience.

Strong knowledge and application of U.S. and international medical device regulations and quality systems, including 21 CFR 807, 803, 806, and 820, EU MDR, MDSAP, and experience working directly with regulatory agencies such as FDA, PMDA, MHLW, and TÜV during and outside of audits. Proven ability to work effectively in cross-functional matrix organizations, collaborate with diverse stakeholders, multitask in fast-paced environments, adapt to changing priorities, and lead through sound judgment and quality-focused decision-making.

Excellent analytical, problem-solving, communication, and technical skills, with the ability to drive results, maintain accountability, apply attention to detail, and communicate effectively both verbally and in writing. Broad technical expertise across disciplines such as Mechanical, Electrical, Biomedical and Systems Engineering, Materials Science, Biology, Neurophysiology, and Statistics, with experience in cochlear implants, medical device electromechanical systems, consumer electronics, biomedical restoration technologies, and AI tools such as ChatGPT, Gemini, and Claude considered advantageous.

Proficiency in English, Microsoft Office, Minitab (or equivalent statistical software), and Solid Works…