Your responsibilities will include:
- Conduct mechanical design activities for developing complex cutting-edge medical device systems through prototyping, testing and modeling.
- Conduct simulation and modeling activities using tools such as FEA and CFD to predict mechanical performance and optimize design parameters
- Develop and validate computational models of mechanical systems using tools such as MATLAB or SolidWorks Simulation
- Perform independent tests, studies, analyses, and interpretations to generate technical conclusions and provide recommendations.
- Assist in DFM (Design for Manufacturing) activities.
- Develop device design history files (i.e., requirements, risk management, usability files.
- Ensure compliance to industry and international standards.
- Develop verification and validation plans, protocols, and reports.
- Conduct work across the full scope of technical and documentation activities for the department.
- Responsible for technical input into project level planning.
- Provide technical guidance to review work plans and advise on unusual features of projects
- Provide technical, project level leadership to engineering assistants or junior engineering staff.
- Participate in failure investigations and repair planning.
- Develop and test new manufacturing processes.
- Support regulatory filings to various government bodies as required.
- Support the development of intellectual property where required.
- Support pre-clinical and clinical research activities where required.
- Other duties as required.
Required Qualifications
- Bachelor’s degree in mechanical or biomedical engineering
- 4+ years of related working experience from a regulated manufacturing industry
- 4+ years of relevant design control experience
- Experience with the overall design and development process
- Experience with leading rapid design iteration and making design recommendations
- Strong hypothesis-driven experimental design and statistical analysis skills
Preferred Qualifications
- Experience focusing on R&D activities in the medical devices industry
- Knowledge of ISO 13485, ISO 14971, 21 CFR part 820, ISO 11135 and ISO 11607
- Self-starter with the ability to quickly learn about new processes
- Excellent analytical and communication skills (both written and oral)
- Able to work independently and in a multidisciplinary team environment
Compensation forhourly, non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for
salaried, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
Compensation foris governed by Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives).