PD Program Manager (Medical Devices)

Location: Fridley, Minnesota, United States; onsite four days per week. Travel is less than 10%.

Salary: $138,400–$207,600 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies across more than 150 countries, focusing on therapies that alleviate pain, restore health, and extend life.

What you will do

• Lead complex, cross-functional programs within the Neuromodulation and Pelvic Health Product Lifecycle Management organization.
• Drive regulatory compliance remediation, manufacturing capacity expansion, product design enhancements, supply continuity, and other portfolio initiatives.
• Develop project plans, schedules, resource allocations, budgets, status reports, and progress-monitoring mechanisms.
• Manage technical risks and issues by coordinating risk burndown plans with technical teams.
• Align stakeholders across R&D, Regulatory Affairs, Quality, Operations, Supply Chain, Manufacturing, Biocompatibility, and Sterilization.
• Gather and manage requirements, resolve project issues, and ensure delivered products address stakeholder and business needs.

Requirements

• Bachelor's degree in Engineering or a technical field with at least 5 years of relevant experience, or an advanced degree in Business, Engineering, or a technical field with at least 3 years of relevant experience.
• Experience leading complex, multi-site programs in a highly matrixed environment.
• Experience with medical device development and operations, including regulatory, quality, manufacturing, or supply chain functions.
• Must have unrestricted U.S. work authorization at hire and throughout employment; sponsorship is not available for roles below Principal level.
• For bachelor's degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice to have

• MBA or another advanced degree.
• PMP, Lean Six Sigma Black Belt, or other project management certification.
• Experience with MDR remediation, FDA 510(k) and PMA submissions, QMS, DHF, DMR, design controls, IEC 60601, IEC 62304, ISO 14971, and ISO 13485.
• Experience interpreting technical data, engineering reports, and statistical analyses.

Culture & Benefits

• Work in a global healthcare technology organization focused on patient impact.
• Regular employees may receive health, dental, vision, life, disability, retirement, paid time off, and paid holiday benefits.
• Additional benefits include 401(k) contributions and matching, employee stock purchase opportunities, tuition assistance, healthcare spending accounts, and an employee assistance program.
• The role includes less than 10% travel.