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$120k–$130k/yr
Full-time
bachelor degree, professional certificate
Posted 10d ago
~40 hrs/week
Responsibilities
Lead cross-functional teams in the development and launch of heart valves and delivery catheters while ensuring regulatory compliance and quality standards. Manage project timelines, budgets, and risks across global teams to meet critical business needs.
Requirements
Requires a Bachelor's degree in Engineering or Biomedical Sciences and at least 3 years of experience in project management within a medical device or R&D environment. PMP certification and experience with FDA PMA or NDA product development are highly desired.
Full job description
Job DetailsJob Location: Irvine, CA 92618Position Type: Full TimeEducation Level: 4 Year DegreeSalary Range: $120,000.00 - $130,000.00 SalaryJob Title: Associate, Project Manager
Supervisor/Manager Title: Senior Director, Program Management
Job Description Summary: Responsible for leading cross-functional teams through the development and launch of heart valves, delivery catheters, and related components, ensuring projects meet regulatory compliance, quality standards, and timelines while managing budgets, risks, and stakeholder expectations within the complex landscape of medical device development and commercialization. Projects may span globally across the organization to address the most critical business needs including Product Development, Operations, Quality and Regulatory.
Job Responsibilities
Project Planning & Execution
Develop comprehensive project plans, including scope definition, timelines, milestones, resource allocation, and budget management. Lead cross-functional teams consisting of engineers, clinicians, regulatory specialists, quality assurance personnel, and marketing teams. Manage project schedules, track progress against key performance indicators, and identify potential roadblocks to mitigate risks. Ensure adherence to regulatory requirements (FDA, ISO, etc.) throughout the product development lifecycle.
Technical Expertise
Understand medical device design principles, functionality, and technical specifications relevant to the project. Collaborate with engineering teams to translate product requirements into technical design documents. Stay updated on emerging technologies and industry trends in medical device development.
Stakeholder Management
Facilitate communication and collaboration between different departments, including clinical research, manufacturing, sales, and marketing. Present project updates and key decisions to senior management and stakeholders. Manage stakeholder expectations and address concerns effectively.
Risk Management
Identify and proactively mitigate potential risks associated with the project, including technical, regulatory, and clinical risks. Develop contingency plans to address unforeseen challenges and ensure project continuity.
Quality Assurance
Ensure compliance with quality management systems (QMS) and standard operating procedures (SOPs) throughout the project. Monitor and address quality issues to maintain product safety and efficacy.
QualificationsEducation, Experience, and Certification:
Bachelor's degree in Engineering, Biomedical Sciences, or a related field. Minimum 3 years’ experience in project management/leading teams to implement product/manufacturing process improvements and/or develop complex line extensions or new products (within R&D, Manufacturing, Quality, Clinical or Regulatory). Experience in FDA environment for PMA or NDA product development is highly desirable. Project Management Professional (PMP) or equivalent project management training certification desired.
Required Skills and Qualifications
Project Management Expertise: Proven experience in managing projects from concept to commercialization, ideally within the medical device industry. Technical Knowledge: Understanding of medical device design principles, manufacturing processes, and regulatory requirements. Must take initiative and have the ability to create/edit/review documentation and timelines using standard MS Office tools. Leadership Skills: Ability to lead cross-functional teams, motivate individuals, and foster collaboration. Communication Skills: Excellent written and verbal communication skills to effectively convey complex technical information to diverse stakeholders. Regulatory Compliance: Familiarity with FDA regulations and other relevant international standards for medical devices. Problem-solving and Critical Thinking Skills: Ability to analyze complex situations, identify root causes, and develop effective solutions. Flexibility: Ability to manage multiple projects/tasks with high attention to detail. Support global teams of varying size and focus across multiple time zones.
Related keywords
Medical DevicesHeart ValvesDelivery CathetersFDAISOPMANDAPMPQMSSOPProduct DevelopmentR&DManufacturingClinical ResearchRegulatory AffairsProject Lifecycle
Aortic regurgitation is different. So is our valve.
Industry
Medical Equipment Manufacturing
Company size
51-200 employees
Founded
2013
Headquarters
Irvine, CA
LinkedIn followers
17,172
Total funding
$342M
JenaValve is a medical device company developing the first transcatheter heart valve technology that is uniquely designed for the minimally invasive treatment of aortic regurgitation (AR).
The JenaValve Trilogy Heart Valve System is the first and only device currently approved in the EU for the treatment of severe, symptomatic aortic regurgitation in patients that are deemed high-risk for surgical aortic valve replacement. The Trilogy System is also CE-Mark approved for treatment of severe, symptomatic aortic stenosis.
In the US, JenaValve has completed enrollment of the ALIGN-AR IDE Clinical Trial which will support a future PMA submission. If approved, the Trilogy System would become the first and only TAVR system in the US indicated for the treatment of symptomatic, severe AR.
JenaValve is headquartered in Irvine, California with offices in Leeds, U.K. and Munich, Germany.
Offices: 4 Cromwell, Suite 100, Irvine, CA 92618, US
How much do Science & Research jobs in California pay?
Based on 11610 listings with disclosed salaries, most science & research jobs in California pay between $102k–$250k per year. Individual offers vary with seniority, company size, and specialization.
How many Science & Research jobs are open in California right now?
There are currently 18,374 open science & research positions in California listed on Clera. New openings are added daily as companies post roles.
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