Senior Mechanical Engineer

3 weeks ago

Montréal QC, Canada FemTherapeutics Inc. Full time

Title: Senior Mechanical Engineer

Location: Montreal, QC

Commitment: Full-Time

Compensation: $90K-120K

Apply By: May 6, 2024

Start Date: ASAP

HOW TO APPLY:

To apply, please send an email to careers@femtherapeutics.com. Please include the title of the position you are applying to in the subject line and attach your resume.

DESCRIPTION:

Founded in 2019 as a spin-off from the McGill Surgical Innovation Program, FemTherapeutics is a medical device company building the "Invisalign model for Gynaecology". Leveraging artificial intelligence and 3D printing, we are developing personalized intra-vaginal devices to treat common pelvic health conditions. Our first product is indicated to manage the symptoms of Pelvic Organ Prolapse and Stress Urinary Incontinence.

As we experience rapid growth, we are excited to welcome a motivated Senior Mechanical Engineer who is eager to learn, grow, and build clinician/patient-focused medical devices as they work towards market launch by 2025. The ideal candidate should be an analytical individual with a strong mechanical/materials engineering background and a passion for medical devices. The Senior Mechanical Engineer will be accountable for engineering the product, employ 3D printing/additive manufacturing techniques, and contribute to material selection. This is an opportunity to join a growing start-up working with cutting-edge technology to modernize treatments for women’s health. This is a hybrid role with at least 3 days of in-person work at our offices in downtown Montreal.

RESPONSIBILITIES:

  • Transform Femtherapeutics' designs into an engineered product, optimized for functionality and production
  • Develop functional prototypes through 3D printing (FDM/SLA) and silicone casting/molding
  • Investigate material suitability for prototyping and design by regularly researching, assessing biocompatibility profiles, and mechanically testing new materials (tensile, compression, cyclic loading, etc.)
  • Develop benchtop test procedures/protocols to support medical device verification and validation activities,
  • Draft and/or review technical documents, such as manufacturing drawings, bills of materials (BOMs), technical summaries, patent development documents, technical journals/papers, etc.
  • Investigate and evaluate polymer manufacturing processes (3D printing, injection molding, blow molding, etc.) to support product development and scaling efforts
  • Commission, qualify, and maintain prototyping, testing, and production equipment
  • Support purchasing, material handling, and inventory management, when necessary,
  • Consider biocompatibility and sterilization requirements throughout the design, material selection, and prototyping processes,
  • Effective communication with other team members and clients to ensure products are provided in a timely and efficient manner to meet R&D milestones and timelines,
  • Develop and implement design controls and quality systems in accordance with relevant regulatory standards (e.g., ISO 13485, FDA QSR),
  • Mentor and coach junior engineers, providing technical guidance and support.

QUALIFICATIONS:

  • Bachelor's degree/Master’s Degree/Ph.D. from an accredited university in Mechanical or Manufacturing Engineering,
  • 3-5 years of experience in product development, preferably in medical devices (or consumer products),
  • Experience with additive manufacturing technologies or injection/blow molding,
  • Knowledge of materials commonly used in medical device manufacturing,
  • Capable of developing and executing mechanical development timelines,
  • Good language and communication skills – both written and verbal.

CONSIDERED AS ASSET:

  • Experience working within a regulated environment considered an asset (preferably ISO:13485 or MDSAP)
  • Supplier/Vendor/Contract Manufacturer management experience is considered an asset,
  • Experience working with Finite Element Analysis (FEA) and simulation testing is considered an asset,
  • Experience working in FemTech would be a competitive asset,

BENEFITS:

  • You will be part of the core team developing and commercializing the first customizable gynecological prosthetic,
  • You will work in a fast-paced environment and experience the growth and scale-up of an early-stage startup,
  • You will collaborate with a small (

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