Medical Devices jobs in Hamilton, ON
- Capgemini SogetiBurlington, ON
- Permanent
- Strong experience with complex medical systems for connected/embedded technologies.
- You will be responsible for ensuring end‑to‑end design quality and…
- Capgemini EngineeringBurlington, ON
- $68,911–$150,350 a year
- Permanent
- Strong experience with complex medical systems for connected/embedded technologies.
- You will be responsible for ensuring end‑to‑end design quality and…
- StrykerHamilton, ON L9H 7L8
- $72,400–$96,600 a year
- Full-time
- Working knowledge of Canadian regulations for medical devices, CTO (cells, tissues, and organs), drugs, natural health products, and cosmetics.
- View all Stryker jobs - Hamilton jobs - Senior Quality Specialist jobs in Hamilton, ON
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- StrykerHamilton, ON L9H 7L8
- $97,100–$129,450 a year
- Full-time
- Experience working with connected medical devices, remote monitoring, cloud-based platforms, software products, mobile applications, AI-enabled solutions, or…
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OmniaBio: Compliance Associate (Environmental Monitoring and Manufacturing) 12-month contract
Easily applyCentre for Commercialization of Regenerative...Hamilton, ON- $65,000–$75,000 a year
- FDA, EMA, ICHQ7, as well as ISO standards) or medical device development.
- Committed to digital transformation, OmniaBio integrates automation, robotics, and…
- View all Centre for Commercialization of Regenerative Medicine jobs - Hamilton jobs - Environmental Monitor jobs in Hamilton, ON
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Mechanical Product Development & Prototyping Designer (Part time /Co Op/ Ful Time)
Easily applyUrgently hiringFYELABS IncorporatedHamilton, ON L8N 1L1- $20–$30 an hour
- Full-time +5
Often responds in 1 day- Mechanical Product Development & Prototyping Designer(Co-op / Part-Time / Full-Time)About FYELABS.
- Thinks in systems and mechanisms.
Sales Associate
Easily applyOften replies in 1 daySenior Helpers of BurlingtonBurlington, ON- $45,000–$55,000 a year
- Full-time
- Experience: Minimum 2–3 years of proven sales and community relations experience in the senior living, home care, medical device, or pharmaceutical industries.
- Bell CanadaHamilton, ON
- $20–$28 an hour
- Full-time +3
- Weekends as needed +1
- Dental care
- Paid vacation
- Flexible schedule
- Competitive hourly wage plus uncapped commission.
- Full benefits package and paid vacation for full-time and part-time employees.
Mobility & Equipment Specialist
Easily applyOften replies in 5 daysAGTA Home Healthcare Hamilton-NiagaraStoney Creek, ON- $19–$24 an hour
- Part-time
- 15 to 30 hours per week
- No previous medical equipment experience?
- Experience with mobility or medical equipment.
- Deliver, install, and safely set up home medical equipment including:
Mobility & Equipment Specialist
Easily applyOften replies in 5 daysAGTA Home Healthcare Hamilton-NiagaraStoney Creek, ON- $19–$24 an hour
- Part-time
- 15 to 30 hours per week
- No previous medical equipment experience?
- Experience with mobility or medical equipment.
- Deliver, install, and safely set up home medical equipment including:
Cantonese Medical Interpreter
Easily applyNewKellyOntario- $23 an hour
- Full-time +1
- Designated paid holidays
- Dedicated personal device (desktop, laptop, or tablet).
- As an interpreter supporting healthcare providers, emergency services, insurance organizations,…
View similar jobs with this employerCapgeminiBurlington, ON- $123,750–$282,000 a year
- Permanent
- Deep Life Sciences industry experience (pharma, biotech, and/or medical devices).
- Drives pre-sales pursuits end to end and provides delivery oversight across…
Counter Sales / Warehouse & Delivery
Easily applyNoble CorporationHamilton, ON- $40,000–$55,000 a year
- Full-time
- Previous experience using Electronic Signature Capture devices.
- Access to training and development programs.
- Pension and RRSP contribution opportunities.
- The Lincoln Electric CompanyHamilton, ON L9H 7L8
- $85,871–$108,000 a year
- Full-time
- Strong familiarity with sensors, actuators, operator controls, protective devices, robots, cable routing, and electromechanical interfaces is an asset.
- YWCA HamiltonHamilton, ON L8P 3C1
- $27.05 an hour
- Must be willing to provide a pre- employment medical examination and annually thereafter.
- Provide physical assistance/support as needed by individual in all…
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OmniaBio: Associate I Quality Assurance (MQA)
Easily applyCentre for Commercialization of Regenerative...Hamilton, ON- $65,000–$75,000 a year
- Sound knowledge of applicable regulatory frameworks and requirements for cell and gene therapy and regenerative medicine, such as GMP, ISO, or medical device…
- View all Centre for Commercialization of Regenerative Medicine jobs - Hamilton jobs - Quality Assurance Analyst jobs in Hamilton, ON
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Sr. Software Developer Quality Engineer- Medical Devices
Sr. Software Developer Quality Engineer- Medical Devices
Job details
Job type
Benefits
Full job description
At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.
.
Location
Hybrid (minimum 3 days onsite) – Andover, MA OR Remote
About the job you’re considering
Capgemini Engineering is seeking a Senior Design Quality Engineer- Medical Devices. You will be responsible for ensuring end‑to‑end design quality and compliance across the product development lifecycle for Class II/III medical devices, including software-driven and active implantable products. Working directly with cross-functional teams, you will drive adherence to design controls, risk management, and SDLC best practices from concept through commercialization and post‑market activities.
Your role
- Serving as the Senior Design Quality Engineer on product development teams, ensuring compliance with design controls(specifically software) across all lifecycle phases (planning, inputs/outputs, verification, validation, transfer, and change management)
- Establishing and maintaining DHF, DMR, and DHR, ensuring complete traceability from user needs through verification and validation evidence
- Responsible for leading and maintaining risk management activities (hazard analysis, FMEA, risk files) and ensuring integration of risk controls into design and validation activities
- Providing quality oversight of software SDLC activities, ensuring compliance with applicable standards (e.g., IEC 62304) and integration with system-level risk management
- Reviewing and approving design, software, and validation deliverables to ensure completeness, consistency, and audit readiness
- Supporting verification, validation, and design transfer activities, ensuring alignment between design outputs and production processes
- Responsible for leading or supporting CAPA, nonconformance investigations, and root cause analysis to drive continuous improvement
- Supporting internal and external audits (FDA, Notified Body, ISO), and contributing to regulatory submissions (e.g., IDE, PMA, EU MDR)
.
Your skills and experience
- Bachelor's degree in Software Engineering, Computer Engineering, Systems Engineering, Biomedical Engineering, Electrical Engineering, or a related technical discipline.
- 10+ years’ experience in FDA regulated, IEC 62304 medical device software environments, with a focus on Software Design Assurance/Control, detailed knowledge of Risk Management (ISO 14971), SDLC and strong understanding of QMS supporting Software Design Controls.
- You have proven experience in Root Cause Analysis, Software V&V, identifying/ supporting processes and design quality tools for use in tracking/preventing software defects, design traceability, Design for Quality (DfQ), Agile, and SAFe
- Experience participating in software design reviews, software architecture reviews, and assessment of software lifecycle deliverables including requirements, architecture/design documentation, traceability, verification, and validation evidence
- Strong experience with complex medical systems for connected/embedded technologies
- You’re able to share knowledge, insights regarding software quality standards, and regulatory requirements
- Experience supporting software-related regulatory submissions and audits (e.g., IDE, PMA, 510(k), EU MDR) and defending software quality and design control documentation
- You have excellent written and verbal communication skills, with the ability to communicate and present to all levels of management.
- Ability to interpret software design and code (C/C++/C# or any other object-oriented language) to verify implementation of requirements.
The base compensation range for this role in the posted location is: 68,911 - 150,350
Capgemini provides compensation range information in accordance with applicable national, state, provincial, and local pay transparency laws. The base compensation range listed for this position reflects the minimum and maximum target compensation Capgemini, in good faith, believes it may pay for the role at the time of this posting. This range may be subject to change as permitted by law.
The actual compensation offered to any candidate may fall outside of the posted range and will be determined based on multiple factors legally permitted in the applicable jurisdiction.
These may include, but are not limited to: Geographic location, Education and qualifications, Certifications and licenses, Relevant experience and skills, Seniority and performance, Market and business consideration, Internal pay equity.
It is not typical for candidates to be hired at or near the top of the posted compensation range.
In addition to base salary, this role may be eligible for additional compensation such as variable incentives, bonuses, or commissions, depending on the position and applicable laws.
Capgemini offers a comprehensive, non-negotiable benefits package to all regular, full-time employees. In the U.S. and Canada, available benefits are determined by local policy and eligibility and may include:
- Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company paid holidays, Personal Days, Sick Leave
- Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
- Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
- Life and disability insurance
- Employee assistance programs
- Other benefits as provided by local policy and eligibility
Important Notice: Compensation (including bonuses, commissions, or other forms of incentive pay) is not considered earned, vested, or payable until it becomes due under the terms of applicable plans or agreements and is subject to Capgemini’s discretion, consistent with applicable laws. The Company reserves the right to amend or withdraw compensation programs at any time, within the limits of applicable legislation.
Disclaimers
Capgemini is an Equal Opportunity Employer encouraging inclusion in the workplace. Capgemini also participates in the Partnership Accreditation in Indigenous Relations (PAIR) program which supports meaningful engagement with Indigenous communities across Canada by promoting fairness, accessibility, inclusion and respect. We value the rich cultural heritage and contributions of Indigenous Peoples and actively work to create a welcoming and respectful environment. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.
This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodation does not pose an undue hardship. Capgemini is committed to providing reasonable accommodation during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact.
Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process.
Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.