3 days ago

Sr. Product Development Engineer

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 13 hours agoStatus: Live

Job Summary

Build and validate consumer medical device and packaging solutions end-to-end, from concept and prototyping through design transfer to manufacturing. Maintain FDA-compliant documentation (including DHFs) and lead design verification/validation and packaging qualification, including seal strength, integrity, and aging studies. Drive human factors engineering activities, apply risk management (ISO 14971), and coordinate testing and regulatory submissions across Quality, Regulatory Affairs, Operations, Supply Chain, and external partners.

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: Communications, PR & Community

Seniority: Mid level

Key Responsibilities

•Perform hands-on mechanical design of consumer medical devices from concept generation through detailed design, prototyping, and design transfer to manufacturing.
•Create and maintain design-compliant documentation, including design inputs/outputs, DHFs, and engineering change orders.
•Execute design verification and validation (V&V), including test protocol authorship, execution, and reporting.
•Lead packaging qualification (e.g., seal strength and package integrity testing) and support sterilization validation activities with external vendors and laboratories.
•Conduct human factors engineering (HFE) activities, including use-related risk analysis and formative/summative usability testing, and coordinate cross-functional regulatory readiness.

Pay and Benefits

Salary: USD 130,000 - 150,000 annually

Perks:Health InsuranceDentalVision401kPaid LeaveParental LeaveEquityEsppRemote Work

Key Requirements

•Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Packaging Engineering, or a closely related field.
•8+ years of engineering experience, including at least 4 years in FDA-regulated medical device or diagnostics product development.
•Working knowledge of 21 CFR 820 (QSR), ISO 13485, and ISO 11607 standards; experience with design controls, DHF documentation, and design V&V.
•Experience authoring and executing packaging qualification or sterilization validation protocols and technical reports.
•Human factors engineering experience per FDA HE75 and IEC 62366-1, including use-related risk analysis and formative/summative usability testing.

Experience:4+ yearsMedical deviceDiagnosticsFDA-regulatedPackagingIVD

Education:Bachelor's in Mechanical Engineering, Biomedical Engineering, Packaging Engineering (or closely related field)

Skills:Written communicationVerbal communicationCross-functional collaboration

Tech Stack:FDA 21 CFR 820 (QSR)ISO 13485ISO 11607ISO 14971FDA HE75IEC 62366-1SolidWorksDHFDMRGD&T

Company Brief

hims & hers

A telehealth and consumer wellness platform offering personalized care and products across sexual health, hair, mental health, dermatology, weight loss and primary care via digital consultations, prescriptions, and fulfillment.

Industry: HealthTech

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: San Francisco, United States

Founded: 2017

Glassdoor: 2.9

Website LinkedIn Glassdoor

Loading job details...

Preparing the role view and application actions.

hims & hers

3 days ago

Sr. Product Development Engineer

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 13 hours agoStatus: Live

Job Summary

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: Communications, PR & Community

Seniority: Mid level

Key Responsibilities

•Perform hands-on mechanical design of consumer medical devices from concept generation through detailed design, prototyping, and design transfer to manufacturing.
•Create and maintain design-compliant documentation, including design inputs/outputs, DHFs, and engineering change orders.
•Execute design verification and validation (V&V), including test protocol authorship, execution, and reporting.
•Lead packaging qualification (e.g., seal strength and package integrity testing) and support sterilization validation activities with external vendors and laboratories.
•Conduct human factors engineering (HFE) activities, including use-related risk analysis and formative/summative usability testing, and coordinate cross-functional regulatory readiness.

Pay and Benefits

Salary: USD 130,000 - 150,000 annually

Perks:Health InsuranceDentalVision401kPaid LeaveParental LeaveEquityEsppRemote Work

Key Requirements

•Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Packaging Engineering, or a closely related field.
•8+ years of engineering experience, including at least 4 years in FDA-regulated medical device or diagnostics product development.
•Working knowledge of 21 CFR 820 (QSR), ISO 13485, and ISO 11607 standards; experience with design controls, DHF documentation, and design V&V.
•Experience authoring and executing packaging qualification or sterilization validation protocols and technical reports.
•Human factors engineering experience per FDA HE75 and IEC 62366-1, including use-related risk analysis and formative/summative usability testing.

Experience:4+ yearsMedical deviceDiagnosticsFDA-regulatedPackagingIVD

Education:Bachelor's in Mechanical Engineering, Biomedical Engineering, Packaging Engineering (or closely related field)

Skills:Written communicationVerbal communicationCross-functional collaboration

Tech Stack:FDA 21 CFR 820 (QSR)ISO 13485ISO 11607ISO 14971FDA HE75IEC 62366-1SolidWorksDHFDMRGD&T

Company Brief

hims & hers

Industry: HealthTech

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: San Francisco, United States

Founded: 2017

Glassdoor: 2.9

Website LinkedIn Glassdoor