Staff / Senior Staff Advanced Manufacturing Engineer, MedTech
Knowles Precision Devices
Salary
💰 $120,000 - $140,000 per year
Job Level
Mid-LevelSenior
About the role
- We are seeking a Systems Engineer to lead the requirements, risk management, system architecture, and usability engineering activities across the product lifecycle. This role is critical in ensuring our products are safe, effective, and compliant with regulatory requirements while enabling cross-functional teams to collaborate effectively. The Systems Engineer will act as the owner of requirements traceability, system architecture documentation, and usability testing, driving high-quality engineering practices that ensure regulatory success and market readiness.
Requirements
- Required: Bachelors degree in Computer Science, Electrical Engineering, Biomedical Engineering, or related field. 5+ years of experience in systems engineering for regulated medical devices or software as a medical device (SaMD). Strong knowledge of FDA, EU MDR, and ISO regulations, including IEC 62304, ISO 14971, IEC 62366, and ISO 13485. Demonstrated expertise in requirements management, traceability, and risk management. Experience conducting usability engineering in compliance with IEC 62366. Excellent technical writing and documentation skills, particularly for regulatory submissions. Familiarity with requirements management tools . Strong cross-functional collaboration skills, with the ability to communicate clearly with engineering, quality, regulatory, and clinical teams. Systems thinking mindset with the ability to manage complexity across hardware, software, and user workflows. Understands and complies with ethical, legal, and regulatory requirements applicable to the medical device industry. Effective leadership, management, and teamwork skills. Strong written and verbal communication skills; proactive cross-functional communicator. Ability to work independently with minimal oversight and direction. Ability to effectively manage and prioritize multiple tasks and projects. Flexibility and adaptability to work in a dynamic and rapidly changing start-up environment. Strong desire and vision to build a new organization with a clear vision. Preferred: Experience with digital health, AI/ML, or diagnostic, or software devices. Experience supporting FDA or international regulatory submissions.
