Senior Program Manager, Product Development

Job Description

Insight Global is seeking a Senior Program Manager to sit within our client's Enterprise PMO and lead cross-functional execution of their next-generation Neurostimulator development program. This person owns the program from Design Verification through FDA submission, regulatory approval, and commercial launch — building integrated plans, driving phase-gate governance, and keeping Hardware (algorithms/embedded software), Digital Product Development, Regulatory, Quality, Marketing, and Commercial aligned on scope, risk, and timeline. This is one of the client's most critical product initiatives, so they need someone who has taken a Class II or III device all the way to market in a highly regulated environment.

Skills and Requirements

• Bachelor's degree in Engineering, Biomedical Engineering, Science, Business, or related field
• 7+ years of program/project management experience
• 4+ years leading complex medical device development programs
• Proven track record taking a product from development through regulatory approval and commercial launch
• FDA submission experience with Class II and/or Class III devices
• Strong command of Design Controls, product development lifecycle, Design V&V, FDA regulatory processes, and quality systems
• Experience leading cross-functional teams without direct authority
• Implantable devices, neurostimulation products, or electromechanical medical systems
• Agile and Stage-Gate development models
• PMO / portfolio governance environments
• Use of generative AI for meeting minutes, dashboarding, reporting, and communications

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].