Product Development Manager, Software

$93,000 - $108,000/Yr

Mighty Oak Medical - Englewood, CO

Full-time - Mid Level

Englewood, CO

Miscellaneous Manufacturing

About the position

Mighty Oak Medical is seeking a Product Development Manager, Software to lead a cross-functional team in the design and development of innovative medical device software. This role focuses on managing software development processes, ensuring compliance with industry standards, and collaborating with various departments to meet product requirements. The ideal candidate will have a strong background in software development for medical devices, particularly in the orthopedic field, and experience in team management.

Responsibilities

• Manage product development team members (up to 5 FTEs)
• Define and design product specifications needed to achieve development goals
• Manage software development and testing of deliverables associated with project requirements
• Collaborate with cross-functional team members on projects
• Manage project tasks and timelines
• Interpret user input and generate software requirements
• Design product components and processes
• Analyze software and product risk
• Plan and execute validation and verification activities
• Write validation protocols, reports, and technical summaries
• Lead design review meetings with members of the engineering, quality, and operations department
• Operate within a quality management system; adhere to strict standards and policies associated with a controlled environment.

Requirements

• Experience developing software as a medical device
• Bachelor's and/or Master's degree in Biomedical Engineering, or related technical discipline
• 5+ years of medical device development experience
• 2+ years of management experience
• Familiarity with FDA and ISO (13485, 14971) Regulations, preferred
• Understanding of software development lifecycle (IEC 62304)
• Cybersecurity risk analysis (NIST Cybersecurity Framework or FDA Cybersecurity Guidance)
• Excellent oral, written, and communication skills
• Strong critical thinking, problem solving, and attention to detail.

Nice-to-haves

• Knowledge or experience with spine surgery or spine industry a plus
• Involvement in the 510k submission process.

Benefits

• 401(k)
• 401(k) matching
• Health insurance
• Paid time off