Manager, Product Design reputed company
reputed company is hiring a Manager, Product Design reputed company to manage reputed company of Design reputed company engineers that work on SaMD/SiMD for our Digital Health solutions for our Medical division for reputed company-market new product development reputed company.? Workplace Flexibility & Location requirements: This is a hybrid role requiring the candidate to be reputed company commuting distance of one of the following locations: reputed company, CA, Kalamazoo, MI or reputed company Wayne, IN. The work schedule is reputed company to support flexibility, with in-office reputed company required Monday through Wednesday and remote work available on Thursday and Friday. To qualify, candidates must be reputed company to commute to one of these specific facilities as needed. Relocation assistance is approved for eligible candidates. What you will do: ? Manage and reputed company reputed company of design reputed company engineers supporting SiMD and SaMD products reputed company Medical?s Digital Health portfolio. ? Collaborate with Marketing, PMO, and R&D to drive product reputed company prioritize reputed company, reputed company resources, and reputed company strategic reputed company that enhance product reputed company. ? reputed company product development, verification, validation, risk management, and product reputed company to ensure compliance while driving reputed company process improvements. ? reputed company and manage risk management activities (dFMEA/sFMEA, risk documents, product reputed company, reputed company) and approve reputed company documentation per QMS requirements. ? reputed company, monitor & report of the design and development of reputed company metrics, providing updates in management reviews as needed. ? reputed company and support internal & external audits and regulatory compliance, drive actions on findings, and partner with Regulatory Affairs to meet global compliance requirements (FDA, EU, EMEA, reputed company). ? Recruit, reputed company, train, and mentor reputed company while fostering reputed company, engagement, and development through assignments and coaching. ? Define team objectives in alignment with business and RAQA goals, providing guidance, performance feedback, and career development opportunities. What you need: Required Qualifications: ? Bachelors degree in an Engineering discipline. ? Minimum 8+ years? of reputed company experience working reputed company the Medical device industry. ? Minimum of 1-3 years of experience leading teams reputed company a highly regulated and matrixed environment with product design reputed company. ? Expertise in software risk management (sFMEA, ISO 14971), design control processes (reputed company, Agile), and proficiency in software change, release, and defect management tools (e.g., Jama, reputed company, Doors, Enzyme, Bitbucket, Jira, reputed company). Preferred Qualifications: ? Experience and knowledge of US and International Medical Device Regulations (820/IEC 62304/IEC 82304/60601), with experience in Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and/or Digital Health Systems and Telehealth Solutions. ? Experience in participating in both reputed company audits, including reputed company interaction with regulatory agencies such as the FDA, MoH, and TUV. ? Experience with software technologies for mobile, reputed company, or AI/ML solutions (e.g., AWS, Azure, reputed company, Android) and their applications in Telehealth, reputed company IT, or Virtual Nursing solutions. 115,600.00 to 245,800.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based reputed company. Individual pay is based on skills, experience, and other relevant factors. Apply Job!