Inspired by design.

Key Responsibilities

• Execute mechanical design activities: CAD (Solidworks preferred), design for manufacturability for a range of manufacturing processes (DFM), design for assembly (DFA), prototyping, testing, engineering analyses including FEA simulation, and technical documentation.
• Oversee the above mechanical design activities of other engineers as a project Technical Lead.
• Drive engineering excellence by acting as a mentor to junior engineers and working with the Director of Mechanical Engineering to improve departmental processes and procedures.
• Oversee and support the planning and preparation of design deliverables and client presentations. Ensure deliverables are met per client expectations and project proposals.

Key Responsibilities

• Apply your knowledge of regulatory guidance around human factors for medical devices to design and conduct formative and summative usability studies.
• Contribute to the design, execution, and reporting on usability research at various stages of product development, with products both consumer and medical in nature.
• Assist in defining user needs, translating those needs into measurable specifications, and completing heuristic reviews of device user-interfaces.
• Work with other researchers to translate uFMEA, risk/hazard analysis, and/or IFU into an appropriate usability testing protocols.
• Assist with moderating and notetaking during research study conduct.
• Support senior members of the team in writing and executing generative and evaluative research protocols, analyzing research insights and data, and writing test reports.

Key Responsibilities

• Maintain responsibility for Design Control initiatives and develop appropriate Design History File documents. Review and approve all Design Control documents and protocols for client projects.
• Support the development and implementation of Validation and Verification plans and activities.
• Drive Risk Management activities and ensure compliance with external standards and regulations.
• Develop and deliver quality assurance and documentation training for all employees.
• Lead QMS team in successful execution of quality policy and objectives, developing internal standard operating procedures and related training content as needed.
• Provide professional, reliable and prompt service to project teams and our clients.