Job Description
We are seeking an experienced Program Manager to lead software and software-enabled medical device development programs within a regulated MedTech environment. This individual will drive cross-functional teams through the full product development lifecycle while ensuring compliance with Design Controls, FDA regulations, and quality standards. The ideal candidate has experience managing complex medical device software programs, Design History Files (DHF), and global product development teams.
Responsibilities
Lead complex medical device software/product development programs.
Manage project plans, timelines, budgets, resources, and risks.
Drive cross-functional collaboration across Engineering, Quality, Regulatory, Product Management, and Manufacturing.
Ensure compliance with Design Controls, ISO 13485, and product development processes.
Oversee DHF deliverables and product lifecycle documentation.
Support verification, validation, regulatory, and commercialization activities.
Provide program status updates to leadership and key stakeholders.
Compensation:
$65-75/hr
Exact compensation may vary based on several factors, including skills, experience, and education.
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
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 opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their 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 recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
8+ years of Program/Project Management experience in Medical Devices, Diagnostics, Digital Health, or MedTech.
Experience leading software or software-enabled product development programs.
Strong knowledge of:
Design Controls
DHF (Design History Files)
ISO 13485
FDA-regulated product development
Risk Management and V&V
Proven experience leading cross-functional teams and managing large-scale programs.
Strong stakeholder management and communication skills.
Nice to Have Skills & Experience
Class II or Class III medical device experience.
Software as a Medical Device (SaMD) experience.
IEC 62304 knowledge.
Agile/Scrum experience.
PMP certification.
Manufacturing transfer and commercialization experience.
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.