Med Device Development - Engineer III

Medical Device Development - Engineer III

Apex Systems is a large staffing and consulting firm and we are looking for a QA Associate with experience in CAD design on software such as Solid Works, cGMP documentation regulations such as ISO 13485, and experience within the medical device industry on device development and design for one of our biotech clients in Toronto.

Client: Biotechnology company

Contract/Perm & duration: 12-month contract

Location: Toronto

This position will be working 4-5 days onsite per week.

Responsibilities:

• Assist in the design of cutting-edge regenerative medicine delivery systems while determining own tasks and appropriate sequence of activities.
• Create engineering documentation (dwg, specs, BOMs, assembly instructions, inspection forms, etc.)
• Develop manufacturing processes for medical devices, components and subassemblies, coordinate prototype and test builds internally and with 3rd party vendors
• Set device and system requirements; create CAD models, prototypes, and design iterations.
• Define design phase gate activities (e.g. design freeze, design V&V, etc.) to advance device development.
• Support the development of intellectual property – invent new technologies, write invention disclosures, aid in preparation of patent filings.
• Author and execute design verification and validation protocols; analyze results and prepare reports.
• Communicate effectively with fellow engineers and non-technical personnel. Write memos, protocols, reports as well as prepare and give presentations.
• Work effectively in cross-functional teams with colleagues in a wide range of areas including cell biology, manufacturing (in-house and third party), quality, regulatory affairs, clinical development, surgery and interventional medicine.
• Collaborate closely with Supply Chain, Quality, and Operations to ensure smooth flow of daily work. Execute pilot manufacturing operations when needed to ensure smooth flow of daily work.
• Support and collaborate with suppliers, including third party manufacturers.
• Support and execute design verification testing – pay close attention to detail to ensure compliance to protocols and accurately record data.
• Identify and implement new R&D tools, test methods, and equipment as needed.
• Other duties as assigned.

Key Qualifications:

• Biomedical or Mechanical Engineering degree, or relevant Engineering degree with a minimum of 4+ years (2 + if Master's Degree) experience in medical device development with a focus on R&D
• Knowledge of design control systems such as ISO 13485 and FDA Quality System Regulation (21 CFR 820)
• Proficiency with 3D modeling software, SolidWorks preferred
• Experience with drafting DHF and DMR documentation
• Strong experimental design and statistical analysis skills
• Hands-on skills such as – prototype assembly, fabrication and design iterations
• Demonstrated analytical skills, especially in the areas of process improvement, problem solving, and logical thinking
• Highly developed organizational skills able to handle multiple high priority tasks/projects concurrently.
• Excellent interpersonal, verbal and written communication skills
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
• Ability to work independently or in teams
• Demonstrated enthusiasm and willingness to learn

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