Senior Product Development Engineer
Summit Search Group, in partnership with ABK Biomedical, are searching for a Senior Product Development Engineer for a permanent position. ABK Biomedical are transforming interventional radiology through the development of proprietary embolization technologies that enhance the treatment of hypervascular tumors and improve patient outcomes. Led by a seasoned leadership team, backed by $30M in recent Series B funding, and driven by a talented group of scientists, engineers and support personnel, they are poised to commercialize their novel radiopaque microspheres technology throughout multiple markets
We’re searching for a Senior Product Development Engineer to plan, design, implement, and test products in line with ABK Biomedical marketing plans. Reporting to the Director of Engineering, in this role you’ll manage projects, deliver cost savings, and develop interventional radiology and embolotherapy products. As an ideal candidate for this role, you’re an experienced Senior Product Development Engineer with a solid background in medical device development. You’re a technical expert with a firm grounding in project management best practices. You thrive in a fast-paced, high-performance environment, and you’re a natural leader, collaborator and problem-solver. This is an outstanding opportunity for a senior-level engineer to join a fast-growing medical device start-up and play a key role in commercializing a ground-breaking new technology.
- Coordinate multidiscipline teams in planning, designing, implementing and testing new products, in line with marketing plans
- Undertaking specific projects as designated in support of business activities.
- Develop and maintain design files.
- Ensure that designs meet specified requirements including regulatory and manufacturing.
- Report project status to management and highlight areas of concern early.
- Generate innovative concepts for new medical device designs to satisfy clinical requirements.
- Lead and participate in concept generation activities, including brainstorming sessions. Refine, rate, rand, and/or otherwise assess concepts.
- Ensure all projects are completed to agreed timelines.
- Contribute where appropriate to regulatory submissions.
- Generate and maintain ECO’s (Engineering Change Orders), protocols, and reports, in compliance with essential regulatory requirements.
- Participate in verification / validation requirements on new product introductions. Develop and execute verification and validation protocols.
- Participate in cost reduction and LEAN manufacturing initiatives where required.
- Bachelor’s degree in an Engineering discipline is required. e.g. Mechanical, Biomedical, Industrial, or equivalent.
- 5+ years product design, development, and manufacturing experience in the medical device industry.
- Hands-on experience with manufacturing tooling, equipment, and process development.
- Experience working with operations to develop strong manufacturing process instructions and operator training to ensure smooth product transition into the manufacturing environment.
- Experience interfacing with suppliers, contract designers, and manufacturers.
- Experience interfacing with medical professionals (physicians, nurses, etc.)
- Experience collaborating with and managing cross-functional teams (Marketing, Production, Quality, Regulatory) to develop and implement solutions over a wide and varied scope.
- Possess 3D modelling and 2D drawing skills with SolidWorks.
- Experience with probability and statistics using Minitab or JMP is an asset.
- Possess a strong working knowledge of medical products lifecycle and demonstrate ability to bring products from concept to market.
- Familiarity with FDA, QSR, and ISO 13485 regulations applicable to the medical device.
- Familiarity with design Failure Mode Effects Analysis (dFMEA) and root cause analysis.
- Must be able to communicate ideas and information clearly, effectively, and frequently (oral and written) within team, company, and outside consultants.
- Efficiency in the management of resources.
- Strong communication and interpersonal skills with the ability to work effectively in a team.
- Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.
- Creative thinker; idea generator; solutions-, results- and action-oriented.
- Highly organized, with exceptional attention to detail.
- Well-suited to a small, fast-paced start-up environment.
*ABK Biomedical is an equal opportunity employer and accommodates people with disabilities throughout the recruitment and selection process.
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If your qualifications are a match for this position please apply online for immediate consideration. Thank you for your application.
Position Applying For:
Senior Product Development Engineer