Product Owner I

• Has authority and accountability to maintain and/or update the product design
• As key team member of the Connected Monitoring Core Team, responsible for providing technical assessment inputs & associated risks in enabling the Business Priority decision for the product and/or design change along with commercial and program inputs
• Ensures consideration of input from external/internal stakeholders (Market, Customer, Regulatory/Compliance, Quality, Service, Manufacturing etc.), drive conflicts to resolution, drive team to agree to a unified decision and drives consideration of these inputs into implementable design solutions
• Works on the technical challenges and risk scenarios and prepares, leads & executes mitigations to ensure optimal results in conjunction with the Sustaining Engineering organization
• Ensures Design Reviews and technical reviews are conducted as required by the quality system
• Approves, controls, and owns Design History File (DHF) elements (may or may not be authoring), Product and Process Changes, including managing the Risk Management Assessment in conjunction with the Product Risk Management Owner
• Responsible to drive continuous adherence to FDA, ISO, and IEC design control procedures, regulations and standards ensuring the product compliance and regulatory changes/new geographic expansion needs
• Utilizes current product knowledge to facilitate change control when required for product support post-market such as SNCR, SCAR, complaint investigation) or updates to the DHF and technical documentation
• Approves 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
• Have the knowledge of the regulatory environment for design, development and manufacturing
• Knowledge of manufacturing practices and improvements (yield improvements, etc.) sufficient to be able to assess changes, incremental risks
• Actively facilitates and negotiates to drive the closure on product/program-related decisions/issues
• 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.

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

• Support for Parents
• Continuing Education/ Professional Development
• Employee Heath & Well-Being Benefits
• Paid Time Off
• 2 Days a Year to Volunteer
• medical and dental coverage
• 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
• time-off benefits such as paid holidays, paid time off
• family and medical leaves of absence
• paid parental leave
• commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• childcare benefits