Senior Product Manager - Medical Devices (Mat Leave)
1 YEAR CONTRACT POSITION WITH POSSIBILITY OF EXTENSION (MATERNITY LEAVE)
Kent Imaging is a leading innovator of medical technology that designs, manufactures, and markets imaging technology for limb preservation and surgical care. Kent is a pioneer in the development of oxygen imaging technology and provides innovative and advanced diagnostic imaging solutions to aid healthcare systems nationally and internationally.
We are seeking a Senior Product Manager – Medical Devices to direct key initiatives for our industry-leading medical imaging device(s). This position represents a great opportunity to bring your unique capabilities and experience to a position and strengthen our product management capabilities.
YOU ARE:
Passionate about technology and committed to improving the lives of patients
Always looking deeper with an impeccable eye for detail
A problem solver who thrives on challenges
Motivated by expectational results and the highest quality standards
PRINCIPAL DUTIES AND RESPONSIBILITIES:
1. Product Development & Lifecycle Management
Work closely with R&D, engineering, marketing, and sales teams to define product requirements and features.
Ensure compliance with FDA, Health Canada, and EU MDR regulations and adherence to industry standards, with a strong focus on ISO 13485, IEC 60601, ISO 14971 and IEC 62304 (software lifecycle processes for medical devices).
Lead cross-functional teams through design, prototyping, testing, V&V (validation and verification) phases, ensuring rigorous compliance with regulatory and quality requirements.
Oversee product lifecycle from concept to launch, including post-market monitoring, risk management and updates.
Analyze market trends, customer feedback, and competitive intelligence to identify growth opportunities.
2. Cross-Functional Collaboration:
Lead efforts in preparing regulatory submissions including 510(k), De Novo, for the FDA, as well as documentation for Health Canada and EU MDR certification.
Partner with quality assurance and regulatory teams to ensure compliance with industry standards, including software V&V per IEC 62304 and FDA software guidance.
Collaborate with sales and marketing teams to understand customer pain points and requirements.
Facilitate cross-functional communication to resolve challenges and meet deadlines.
3. Product Strategy and Roadmap:
Participate in the development of the product roadmap for assigned medical devices, aligning with company goals and market opportunities.
Monitor post-market performance and collaborate with engineering teams on software updates, risk management, and ongoing compliance.
QUALIFICATIONS (EDUCATION, SKILLS, EXPERIENCE):
7+ years experience in product management with medical device experience.
Prior experience overseeing software and hardware products is considered an asset.
Strong understanding of ISO 13485, IEC 60601 and IEC 62304 is considered an asset
Excellent leadership, communication, and interpersonal skills.
WHY WORK AT KENT:
Competitive salary and benefits package
The opportunity to make a measurable impact in a dynamic and growing company
Spacious office in Calgary's Beltline, close to transit and shopping
Interested candidates are to send a cover letter and resume to Jennine Kelly at jkelly@jenninekellyhrconsulting.com
We are an equal opportunity employer and value diversity at our company. We strongly encourage all qualified candidates to apply.