Senior Project Management Consultant establishing INVENSITY in the Swedish market. Managing complex customer projects and developing strong client relationships while leading project teams.
About the role
- Senior Project Manager responsible for software project management in medical device development. Overseeing risks, resources, and timelines to ensure successful project delivery.
Responsibilities
- Plan, execute, manage risk, manage critical path, and commercialize software projects according to strict deadlines and within budget
- Engage resources and coordinate the efforts of team members, third-party organizations, and clients to deliver projects according to plan
- Create project team governance to engage cross-functional accountability of costs, schedules, scope, resources, and track risks of projects
- Analyze project risks and identify their impact while developing mitigation strategies
- Ensure appropriate project level definition across all stakeholders and manage the project from concept to commercialization
- Manage day-to-day operational aspects of a project and scope
- Comply with the Stage Gate Process quality system and help enforce standard operating procedures (SOPs)
- Mitigate team conflict and communication problems
- Motivate team to work together in the most efficient manner
- Own and create appropriate levels of governance to ensure alignment and clear objectives
- Accountable for product compliance to design history file, regulatory standards, and QMS procedures
Requirements
- 5 plus years of project management experience leading medical device development
- Experience with medical device development under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems
- Technical project management in software product development
Benefits
- 401(k) with up to a 6% employer match and no vesting period
- Employee stock purchase plan
- Flexible time off for salaried employees
- Accrual of three to five weeks’ vacation annually for hourly employees (based on tenure)
- Accrual of up to 64 hours of paid sick time annually
- Paid and/or floating holidays
- Parental leave
- Short- and long-term disability insurance
- Tuition reimbursement
- Health and welfare benefits
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