Principal Program Manager
Why Join ACIST?
We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the ACIST team has the power to make a difference......every day!
At ACIST, every employee and every product has the power to make a difference!
We develop, manufacture, and market new and existing products that empower our customers to better diagnose and treat their patients. Our diagnostic and interventional products simplify the complexities of the cardiac cath lab in order to improve the quality of life for our patients around the globe.
Manage and lead product development projects ensuring consistency with corporate strategy, company policies, and regulations. Ensure product performance to customer/functional specifications is in balance with deadlines and budgets. This includes identifying resources and coordinating the efforts of cross-functional project team members to deliver projects according to plan.
Primary Duties and Responsibilities:
- Lead cross-functional teams including Design, Manufacturing Operations, Supply Chain Planning, Category Management, Sourcing, Contract Manufacturers / OEM, Supplier Quality, through the product development process to ensure successful completion of development projects and business goals.
- Responsible for developing, communicating, and documenting project strategies and detailed schedule creation and maintenance
- Monitor the project from initiation through delivery, develops mechanisms for monitoring project progress and provides update to senior management teams.
- Manages the development and implementation process of a company's products and services involving departmental or cross-functional teams focused on the delivery of new or existing products per product development cycle.
- Reviews status of projects; manages schedules and prepares status reports on regular basis.
- Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives.
- Proposes modifications to functional operating policies and day-to-day processes. Problems and issues faced are complex, difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem.
- Communicates with internal and external customers and vendors regarding ongoing operations. Uses information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties.
- Overall value stream development and process responsibility from technology through market release.
- Manages one or more developed or mature programs with well-defined program plans and delivery methodologies
- Ensure all aspects of Quality System Compliance, Design History File, and Regulatory Submissions documentation
- Coordinate Development builds through product verification/validation
- Lead design reviews & utilize analytical skills to drive technical decision-making.
Qualifications (Knowledge, Skills & Abilities):
- Bachelor of Science Engineering degree in Science, Engineering and 9+ years of relevant experience or Master’s degree and 6+ years or relevant experience in following areas:
- Experience in new R&D product / new process development including launch
- Project Management: Experience leading a complex project/program including strong PMP certification
- Proven track record of successfully managing large scale projects
- Strong written and verbal communication skills and interpersonal skills to effectively translate ideas, concepts and information
- Ability to work with different internal and external customers in a professional manner
- Proven experience to work cross-functionally across an organization, at all levels of the organization
- Working knowledge and experience with quality systems regulations and guidelines, ISO, cGMP, Medical Device Directive (MDD), Canadian Medical Device regulations, Japanese PAL and FDA regulatory requirements
- Ability to travel both domestically and internationally
- Certification in project management or equivalent
- Advance degree in business or technology
- Experience leading new product development projects/programs
- Experience leading catheter/consumable projects
- Travel expected to be less than 20%.