Software Project Manager (Medtech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Software Project Manager (Medtech): Leading software development projects for hearing technology platforms with an accent on regulatory compliance and desi control. Focus on coordinating cross-functional teams, managing risk under IEC 62304/ISO 13485, and integrating agile delivery with medical device standards.
Location: Primarily remote, with preference for candidates in the Glenview/Chicago area for occasional onsite collaboration
Salary: $110,000 – $125,000 per year
Company
is a global leader in intelligent hearing, audio, video, and gaming solutions, employing 7,000 people worldwide.
What you will do
- Lead software development projects as Epic Owner within a medical device context.
- Plan and coordinate project execution in aliment with regulatory requirements and desi control processes.
- Collaborate with product owners, commercial teams, hardware/embedded specialists, and regulatory affairs.
- Ensure documentation, traceability, and regulatory compliance are integrated into the delivery process.
- Monitor essential KPIs and manage risks according to IEC 62304 and ISO 13485 standards.
- Represent project teams in governance and reporting, including milestone reviews with quality stakeholders.
Requirements
- Experience delivering software in regulated environments such as medical devices or pharma.
- Knowledge of IEC 62304, ISO 13485, FDA, or EU MDR.
- Proven experience in Agile/SAFe environments balancing pace with compliance rigor.
- Relevant technical degree or equivalent professional experience.
- Proficiency in English, both oral and written.
Nice to have
- Certification in project management methods (PMP, Prince2).
- Experience with hardware or embedded systems.
- Interest in AI-enabled ways of working and process improvement.
Culture & Benefits
- Opportunity to work on software that directly improves people's ability to hear and connect.
- Inclusive and collaborative team environment within a global technology leader.
- Competitive benefits package including health insurance and a 401(k) plan.
- Annual bonuses, paid vacation, and holidays.
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