We are seeking a highly skilled and execution-focused Product Manager to join our team in the medical device space. This role is ideal for someone with a strong background in hardware product development, particularly with COTS (Commercial Off-The-Shelf) components and customization, and a proven track record of commercial product launches. You will play a critical role in driving product execution, ensuring compliance with quality systems, and delivering innovative solutions to market on time.
Key Responsibilities
Lead the end-to-end product lifecycle from concept through commercialization for hardware-based medical devices.
Collaborate cross-functionally with engineering, quality, regulatory, and marketing teams to ensure successful product development and launch.
Translate customer and market needs into clear product requirements and roadmaps.
Manage timelines, deliverables, and resources to meet aggressive deadlines.
Ensure all product development activities comply with Quality Management System (QMS) standards and regulatory requirements.
Work closely with hardware engineering teams to guide technical decisions and resolve issues.
Rapidly ramp up on new technologies and product lines to contribute immediately to ongoing initiatives.
Compensation:
$60/hr to $ 75/hr
Exact compensation may vary based on several factors, including skills, experience, and education.
Benefit packages for this role will start on the 31st 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.
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710 years of experience in product management, with a strong focus on execution and commercial product launches.
Proven experience in the medical device industry, with a deep understanding of regulatory and compliance requirements.
Solid background in hardware engineering; experience with COTS components and customization is highly preferred.
Strong knowledge of QMS and experience working within regulated environments (e.g., FDA, ISO 13485).
Ability to thrive in a fast-paced, deadline-driven environment and quickly adapt to new challenges.
Excellent communication, leadership, and cross-functional collaboration skills.
Experience launching Class II or Class III medical devices.
Familiarity with design controls, risk management, and post-market surveillance processes.
Benefit packages for this role will start on the 31st 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.