Product Owner I - Relocation Assistance Provided

• Maintain and/or update the product design
• Provide technical assessment inputs & associated risks
• Ensure consideration of input from external/internal stakeholders
• Work on technical challenges and risk scenarios
• Ensure Design Reviews and technical reviews are conducted
• Approve, control, and own Design History File (DHF) elements
• Drive continuous adherence to FDA, ISO, and IEC design control procedures
• Facilitate change control when required for product support post-market
• Approve the impact assessment of the change and necessary actions

• Bachelors Degree in Computer Science, Mechanical, Electrical, Biomedical Engineering or other relevant subject areas with 5+ years of proven experience
• 5+ years in product design, systems and risk engineering within the medical device industry
• Proven track record in software-enabled product development, especially involving connectivity (Bluetooth, Wi-Fi)
• Proven application of knowledge in Hardware, Software, and System engineering
• Knowledge of the regulatory environment for design, development and manufacturing
• Knowledge of manufacturing practices and improvements
• Ability to work collaboratively as part of a global multi-functional team

Familiarity with IEC, ISO, FDA and other regulatory standards and GMP/QSR environment preferred

• Medical and dental coverage starting on day one
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP)
• 401(k) Retirement Savings Plan (RSP)
• Flexible Spending Accounts
• Educational assistance programs
• Paid holidays
• Paid time off ranging from 20 to 35 days based on length of service
• Family and medical leaves of absence
• Paid parental leave
• Commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• Childcare benefits