Sonova

1 month ago

Senior Engineer, Design Assurance (Valencia (CA), United States)

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 14 hours agoStatus: Live

Job Summary

Senior Design Assurance Engineer responsible for compliance to design control procedures for software, firmware and hardware for Cochlear Implant Technology. Leads regulatory alignment (21 CFR 820, ISO 13485, ISO 14971, IEC 60601, MDSAP, MDR) within a multidisciplinary team, ensuring designs meet regulatory requirements and product specifications through testing strategies and CAPA processes.

Location: United States

Workplace: Hybrid

Employment Type: Full time

Job Function: Design (Product/UX/UI/Visual)

Seniority: Sr. Manager level

Key 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.

Pay and Benefits

Salary: USD 100,320 - 150,480 annually

Perks:MedicalDentalVision401kPaid Leave

Key Requirements

•Bachelor’s degree in Engineering or a related technical discipline; training in Design for Manufacturability, Design for Six Sigma, and Lean principles preferred.
•Minimum 8 years of product development and/or design assurance experience, including at least 5 years supporting Class III medical devices.
•Strong knowledge and application of U.S. and international medical device regulations and quality systems (21 CFR 820, EU MDR, MDSAP).
•Experience working with regulatory agencies (FDA, PMDA, MHLW, TÜV) during audits or submissions.
•Proven ability to work effectively in cross-functional matrix organizations and lead quality-focused decisions.

Experience:8+ yearsMedical devicesBiomedical

Education:Bachelor's in Engineering

Skills:Regulatory complianceDocumentationCommunicationLeadershipProblem-solving

Languages:English

Tech Stack:SolidWorksMinitabMicrosoft OfficeDV/V21 CFR 820ISO 13485ISO 14971IEC 60601MDSAPMDR

Company Brief

Sonova

Designs, manufactures, and distributes hearing care solutions including hearing aids, cochlear implant accessories, and wireless communication devices, serving audiologists and consumers worldwide through clinics, retail networks, and distribution partners.

Industry: Medical Devices

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Stäfa, Switzerland

Founded: 1947

Website

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Sonova

1 month ago

Senior Engineer, Design Assurance (Valencia (CA), United States)

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 14 hours agoStatus: Live

Job Summary

Location: United States

Workplace: Hybrid

Employment Type: Full time

Job Function: Design (Product/UX/UI/Visual)

Seniority: Sr. Manager level

Key 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.

Pay and Benefits

Salary: USD 100,320 - 150,480 annually

Perks:MedicalDentalVision401kPaid Leave

Key Requirements

•Bachelor’s degree in Engineering or a related technical discipline; training in Design for Manufacturability, Design for Six Sigma, and Lean principles preferred.
•Minimum 8 years of product development and/or design assurance experience, including at least 5 years supporting Class III medical devices.
•Strong knowledge and application of U.S. and international medical device regulations and quality systems (21 CFR 820, EU MDR, MDSAP).
•Experience working with regulatory agencies (FDA, PMDA, MHLW, TÜV) during audits or submissions.
•Proven ability to work effectively in cross-functional matrix organizations and lead quality-focused decisions.

Experience:8+ yearsMedical devicesBiomedical

Education:Bachelor's in Engineering

Skills:Regulatory complianceDocumentationCommunicationLeadershipProblem-solving

Languages:English

Tech Stack:SolidWorksMinitabMicrosoft OfficeDV/V21 CFR 820ISO 13485ISO 14971IEC 60601MDSAPMDR

Company Brief

Sonova

Industry: Medical Devices

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Stäfa, Switzerland

Founded: 1947

Website