Senior Product Development Engineer

femtherapeutics; Montreal; Híbrido; CAD 90.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary + stock options

Medical and dental coverage

Hybrid work: 3 days in-office, 2 days

Vacation 3 weeks + 2 sick days + year‑

Team activities and social events

Office in downtown Montreal (Sherbroke

Descripción de la vacante

femtherapeutics is building the first OTC pessary for pelvic organ prolapse and postpartum recovery. The Senior Product Development Engineer will own end-to-end development, from verification through design transfer, in a hybrid Montreal-based role.

Responsibilities include managing design controls, ISO 14971 risk file, verification protocols, and coordination with contract manufacturers while maintaining budget and timelines. Experience with SolidWorks and 3D printing is preferred.

Formación

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering or related field.
• 5+ years in product design and development for mechanical/biomedical devices or related leadership roles.
• Thorough ISO 13485 knowledge with design controls and supplier controls.
• Experience with ISO 14971 risk management for regulated medical devices.
• Hands-on verification testing: fixtures, protocols to recognized standards, data analysis.
• Experience leading design transfer with contract manufacturers and suppliers.
• Contributed to a 510(k) or comparable submission.
• Proficiency in SolidWorks and FDM/SLA 3D printing.

Responsabilidades

• Own the product development plan and strategy, manage risks with mitigation plans, deliver on time and budget.
• Design, model and optimize the device in SolidWorks from prototype to final product.
• Maintain design controls and the traceability matrix, conduct design reviews.
• Keep ISO 14971 risk file current with design changes and test results.
• Develop and validate test methods, write verification protocols and report results.
• Run the in-house lab and coordinate external testing (aging, biocompatibility).
• Work with contract manufacturers on design outputs and DFM, lead design transfer.
• Support supplier qualification and Quality/Supplier Agreements.
• Prepare predicate data for the 510(k) as needed.
• Follow ISO 13485 in day-to-day work; keep documents audit-ready.
• Flag issues early and propose engineering solutions.

Conocimientos

5+ years in product design and dev

ISO 13485 knowledge

ISO 14971 risk management

verifications testing

design transfer with manufacturers

510(k) submissions

SolidWorks proficiency

FDM/SLA 3D printing

Educación

Bachelor's in Biomedical or Mechanical Engineering

Herramientas

SolidWorks

FDM 3D printing

SLA 3D printing

Descripción del empleo

femtherapeutics is transforming access to pelvic health by creating a better entry point for people experiencing pelvic conditions. The company's flagship product is world's first home-use pessary for pelvic organ prolapse and postpartum recovery, designed for self-management without a prescription or clinic visit. This device is delivered alongside a digital platform that supports clinical screening, education, and care navigation. Through this combination of hardware and software, femtherapeutics provides direct access to screening and treatment across pelvic health needs from postpartum through postmenopause. femtherapeutics has raised over $7M+ from venture capital and institutional funds, been featured in Forbes and Fast Company, and has been named by CIX as one of the Top 20 Innovative Companies in Canada and by Mastercard in Canada's Small Business 100 list.

Role Description

The Senior Product Development Engineer is a full-time, hybrid role based in Montreal, QC, with flexibility for partial work from home. We're building the first OTC pessary for pelvic organ prolapse and postpartum recovery and are currently in V&V on the way to a 510(k). We're looking for a Senior Product Development Engineer who can take the device from verification through design transfer. This role owns the product's development end to end: design controls and the traceability matrix, the ISO 14971 risk file, verification protocols and test method validation, and the bench testing sections of the 510(k). It also covers running our in-house lab, working with contract manufacturers on design outputs and DFM, and leading design transfer, including oversight of process validation (IQ/OQ/PQ). The ideal candidate has hands-on experience designing regulated medical devices in SolidWorks and taking them through verification, and wants to own the product's plan, timeline, and budget while staying close to the work.

Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering or a related field
• 5+ years in product design and development as a mechanical, biomechanical or R&D engineer, or as an R&D or product development manager
• Thorough working knowledge of ISO 13485 and experience applying it on real projects, including design controls, document and change control, and supplier controls
• Experience with ISO 14971 risk management for regulated medical devices
• Hands-on verification testing experience: setting up fixtures and equipment, writing and running protocols to FDA-recognized consensus standards (e.g., ASTM, ISO), analyzing the results, and working with external test labs
• Experience leading design transfer with contract manufacturers and suppliers, including process validation (IQ/OQ/PQ)
• Contributed to a 510(k) or comparable submission (e.g., Health Canada, EU MDR), including writing performance testing sections
• Proficiency in SolidWorks and FDM/SLA 3D printing

Job Responsibilities

• Own the product development plan and strategy, manage project risks with clear mitigation plans, and deliver on time and on budget
• Design, model and optimize the device in SolidWorks from prototype to final product, prototyping on our FDM and SLA 3D printers
• Own design controls: refine design inputs so requirements stay testable, maintain the traceability matrix (user needs - requirements - risk controls - verification - validation), run design reviews, and maintain the Design History File
• Keep the ISO 14971 risk file current as designs and test results change, including the hazard analysis, FMEAs, and links from risk controls to verification evidence
• Develop and validate test methods, then write, execute and report on verification protocols (bench-top, functional and material), updating the verification plan as needed
• Run the in-house lab, including equipment qualification, calibration, maintenance and jig design
• Coordinate external testing, including accelerated aging (ASTM F1980), distribution and biocompatibility (ISO 10993)
• Work with our contract manufacturers on design outputs (drawings, specs, inspection and test plans) and DFM, and lead design transfer, including review of process validation (IQ/OQ/PQ)
• Support supplier qualification and Quality and Supplier Agreements, and define incoming inspection and acceptance criteria
• Write the bench testing sections and predicate comparison data for the 510(k), per FDA performance testing guidance, and support the usability study protocol and IRB paperwork
• Apply ISO 13485 in day-to-day engineering work, write and revise controlled documents under document control and change control SOPs, and keep design records and experiments audit-ready
• Flag technical problems early and bring solutions, working closely with internal and external teams

At fem, we value our employees and offer a comprehensive benefits package:

• Competitive salary + stock options so you can own a piece of what we're building.
• Comprehensive group benefits including medical and dental coverage.
• Hybrid work arrangements, with 3 days in the office and 2 days remote.
• 3 weeks of vacation (+ 2 Sick Days) + Paid holiday closure in December so you can fully enjoy the festive season.
• Quarterly team activities and social events to foster a collaborative and fun work environment.
• A beautiful office environment located on Sherbrooke/Crescent right in the heart of downtown Montreal.