Closed listing
Staff Engineer
- Toronto, ON, Canada
$42 to $50 USD / hour · Contract
This opening has closed.
The original listing is kept below for reference.
Job details
- Pay
- $42 to $50 USD / hour
- Job type
- Contract
- Closing date
- Posting language
- English
- Posted
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Search current openingsOriginal job description
Archived listing. The details below describe a past opening.
Job Description:
Medical Device Development - Engineer III
Client: Biotechnology company
Contract/Perm & duration: 12-month contract
Location: Downtown Toronto, this position will be working 4-5 days onsite per week.
Pay Rate: $42-50/hr
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.
- 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
Everforth Apex Benefits Overview: In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA.
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Everforth Apex Systems is part of the Commercial Segment of Everforth, Inc.
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Glen Allen, Virginia 23060
Everforth Apex is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Benefits Department at [email protected] or 804-523-8228. (Do not submit resumes or solicit consultants to this email address). UnitedHealthcare creates and publishes the Transparency in Coverage Machine-Readable Files on behalf of Everforth Apex.
More about this job
Responsibilities
The engineer will design regenerative medicine delivery systems, develop manufacturing processes, and create engineering documentation including CAD models and prototypes. They will also execute design verification and validation protocols while collaborating with cross-functional teams in quality, regulatory, and clinical development.
Requirements
Candidates must hold a degree in Biomedical or Mechanical Engineering with at least 4 years of experience in medical device R&D. Proficiency in design control systems like ISO 13485 and FDA regulations, along with strong 3D modeling skills, is required.
Skills
- Medical device development
- R&D
- ISO 13485
- FDA Quality System Regulation
- SolidWorks
- 3D modeling
- Engineering documentation
- Manufacturing processes
- CAD
- Design verification
- Design validation
- Experimental design
- Statistical analysis
- Prototype assembly
- Problem solving
- Process improvement
Benefits
- Training program
- Certification preparation
- Technical and leadership courses
- Certification discounts
Visa sponsorship
Not detected in the job text
Categories
- Engineering
- Healthcare
- Manufacturing
- Science & Research
- Technology
Keywords
- Medical Device
- Regenerative Medicine
- R&D
- ISO 13485
- FDA 21 CFR 820
- SolidWorks
- CAD
- DHF
- DMR
- BOM
- Design Verification
- Design Validation
- Statistical Analysis
- Prototyping
- Manufacturing
- Quality Assurance
- Regulatory Affairs
- Biomedical Engineering
- Mechanical Engineering
- Intellectual Property
- Patent Filings
- Supply Chain
- Operations
- Process Improvement
- Cross-functional Teams