Senior Product Development Engineer

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 field5+ years in product design and development as a mechanical, biomechanical or R&D engineer, or as an R&D or product development managerThorough working knowledge of ISO 13485 and experience applying it on real projects, including design controls, document and change control, and supplier controlsExperience with ISO 14971 risk management for regulated medical devicesHands-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 labsExperience 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 sectionsProficiency in SolidWorks and FDM/SLA 3D printingJob Responsibilities
Own the product development plan and strategy, manage project risks with clear mitigation plans, and deliver on time and on budgetDesign, model and optimize the device in SolidWorks from prototype to final product, prototyping on our FDM and SLA 3D printersOwn 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 FileKeep the ISO 14971 risk file current as designs and test results change, including the hazard analysis, FMEAs, and links from risk controls to verification evidenceDevelop and validate test methods, then write, execute and report on verification protocols (bench-top, functional and material), updating the verification plan as neededRun the in-house lab, including equipment qualification, calibration, maintenance and jig designCoordinate 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 criteriaWrite 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 paperworkApply 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-readyFlag technical problems early and bring solutions, working closely with internal and external teamsAt 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.
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