Product Development Manager

3 weeks ago

Bloomington, United States Fasikl Full time

Job Title: Product Development Manager

Company: Fasikl Inc.

Location: Bloomington, MN


About Us:

Fasikl is a pioneering neuro-AI company focused on developing technologies that synchronize sensory and motor neural signals. Fasikl is developing an implantable peripheral nerve systems for intuitive end-effector control and pain management, as well as a wearable system for the treatment of movement disorders. Fasikl has obtained two simultaneous FDA Breakthrough Device Designations for its implantable systems, with MindForceTM Nerve-Computer Interface (NCI) admitted into FDA’s Total Product Life Cycle Advisory Program (TAP). With a steadfast commitment to advancing Neuro-AI technologies, Fasikl Inc. is dedicated to harnessing these technology breakthroughs to improve human wellbeing.


Position Overview:

We are seeking a highly skilled and motivated Product Development Manager to join our dynamic team. The successful candidate will play a crucial role in driving the development of our breakthrough implantable nerve-computer interface device from prototype to commercialization. This individual will work with cross-functional teams, manage project timelines, and ensure that our products meet regulatory requirements and market demands.


Responsibilities:

·      Support the development of new medical devices, from prototype through the design control process, to regulatory approval and commercialization.

·      Collaborate with cross-functional teams, including engineering, clinical affairs, regulatory affairs, quality assurance, and marketing, to ensure alignment and successful execution of project objectives.

·      Develop project plans, timelines, and budgets, and track progress against milestones to ensure timely delivery of high-quality products.

·      Manage and prioritize multiple projects simultaneously, ensuring that resources are allocated effectively to meet project goals.

·      Drive product development activities in compliance with regulatory requirements, including FDA regulations, ISO, IEC, and other standards.

·      Conduct risk assessments and implement mitigation strategies throughout the product development process.

·      Contribute to a culture of innovation and continuous improvement within the product development team.

·      Stay abreast of industry trends, emerging technologies, and competitive landscape to inform product development strategies.

·      Build and maintain relationships with key stakeholders, including healthcare professionals, opinion leaders, and strategic partners.


Qualifications:

·      Bacheller’s degree in engineering, life sciences, or a related field; advanced degree (e.g., MS, PhD) preferred.

·      Minimum of 3 years of experience in product development within the medical device industry, with a proven track record of bringing products from concept to commercialization.

·      Direct experience with implantable programmable electrical medical systems (PEMS) is desirable, experience with neurological devices is a plus.

·      Strong understanding of medical device regulations, including FDA 510(k) and PMA requirements, as well as ISO 13485, ISO 14971, and other relevant standards.

·      Experience managing cross-functional teams and leading complex projects in a fast-paced environment.

·      Excellent communication, leadership, and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.

·      Proven ability to think strategically, solve problems, and make data-driven decisions.

·      Highly organized with strong project management skills and the ability to prioritize competing demands.

·      Demonstrated ability to thrive in a dynamic, entrepreneurial environment and adapt to changing priorities.


Benefits:

·      Competitive salary commensurate with experience

·      Stock options

·      Comprehensive benefits package, including medical, dental, and vision coverage

·      Company matched 401(k)

·      Onsite fitness center (subsidized)

·      Opportunity for professional growth and advancement in a rapidly growing company

·      Collaborative and inclusive work environment


If you are passionate about driving innovation in healthcare and making a meaningful impact, we encourage you to apply for this exciting opportunity to join our team at Fasikl. Please submit your resume and cover letter outlining your qualifications and relevant experience. We look forward to hearing from you

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