Process Development Engineer
Our client ABK Biomedical is 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 Process Development Engineer to own the management, improvement and performance of our manufacturing equipment, processes, products and resources. Reporting to the Director of Engineering, in this role you’ll manage projects, deliver cost savings, and implement best practice methodologies to optimize our high temperature and material processing operations. As an ideal candidate for this role, you’re an experienced Process 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 an intermediate-level engineer to join a fast-growing medical device start-up and play a key role in commercializing a ground-breaking new technology.
- Develop and optimize processing techniques to produce high-precision microspheres from raw materials.
- Design, implement, and validate capital projects using effective project management tools and techniques, in compliance with essential regulatory requirements.
- Provide technical expertise to solve processing problems. Design experiments, develop protocols, execute, collect data, analyze, and interpret results.
- Design fixtures and jigs to assist in execution of engineering studies.
- Monitor equipment and process flows to ensure high levels of performance and Overall Equipment Effectiveness (OEE) or Overall Process Effectiveness (OPE).
- Monitor process performance in terms of personnel, equipment and process capability, material inputs and planning demands.
- Set out and present plans for the improvement of processes, efficiencies and production methodologies.
- Assess standard costs assigned to processes through measurement of Takt times and resource requirements. Make recommendations of appropriate changes to the management team (followed by implementation of agreed changes).
- Continuously focus on ways to reduce change-over times, scrap and non-value-added activities.
- Implement and execute training plans for operators, with follow-up auditing to check training effectiveness.
- Co-ordinate the planning and execution of line trials with appropriate personnel.
- Oversee equipment maintenance and calibration.
- Generate and maintain ECO’s (Engineering Change Orders), protocols, and reports, in compliance with essential regulatory requirements.
- Participate in verification / validation requirements on new equipment introductions / processes / process changes. Develop and execute verification and validation protocols.
- Manage the implementation of LEAN activities to improve process layout and line ergonomics.
- Ensure process controls are implemented as required.
- Bachelor’s degree in an Engineering discipline is required. e.g. Mechanical, Biomedical, Chemical, or equivalent.
- 3+ years previous related experience in a medical device, pharmaceutical, or similar industry.
- Experience in high temperature processing of materials is an asset.
- Working knowledge of medical device quality & regulatory requirements is an asset.
- Experience collaborating with and managing cross-functional teams (Marketing, Production, Quality, Regulatory) to develop and implement solutions over a wide and varied scope.
- Experience with process development tools such as Design of Experiments (DoE), Gauge Repeatability and Reproducibility (GR&R), and gauge capability.
- Experience with risk assessment tools such as Process Failure Modes Effects Analysis (pFMEA), hazard tables, and traceability matrixes.
- Experience with root cause analysis tools such as 5-Whys and Fishbone diagrams.
- Experience with process validation and GMP including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Experience with 3D modelling and 2D drawing using SolidWorks is an asset.
- Experience applying LEAN tools / Six Sigma techniques to improve processes and performance is an asset.
- Strong communication and interpersonal skills with the ability to work effectively in a team.
- Analytical problem-solving abilities.
- 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.
If your qualifications are a match for this position please apply online for immediate consideration. Thank you for your application.
Position Applying For:
Process Development Engineer