POSITION SUMMARY
This position is responsible for planning, directing and coordinating activities of designated projects to ensure that goals or objectives of projects are accomplished within prescribed time frames and budgets. This position is the primary contact for the transfer of customer related information and is responsible for managing and coordinating customer design efforts from product development to production.
ESSENTIAL DUTIES AND RESPONSIBILITIES (other duties may be assigned)
- Follow Employee guidelines and Quality System Regulations as defined by Nissha Medical Technologies practices, policies and Standard Operating Procedures to ensure that customer requirements and industry standards and or regulations are met.
- Direct and manages projects and product development from start to finish.
- Review product designs and establishes project plans. Review time frames, costs, and procedures for accomplishing every phase of awarded projects.
- Work with Business Development and/or Sales to complete all NMT legal agreements. Ensure that a User Requirement Specification form (URS), NDA, Buyout, and Supply Agreement have been completed.
- Procure product specifications from customer; communicates and transfer product specifications to the project/product development team.
- Manage cross-functional project teams during all phases of product development.
- Identify and confer with project/product development team to outline work plan and to assign duties, responsibilities, and scope of authority.
- Direct the activities of project/product development team to review the function, performance, safety, statutory, critical to quality, and regulatory requirements of each project; work within QMS, FDA, and CE guidelines.
- Coordinate the activities of project/product development team members to ensure that the project progresses on schedule and within prescribed budget.
- Conduct design reviews with customer and internal design teams.
- Support cost estimating and quoting through development process.
- Confer with project/product development team on product design for manufacturability.
- Manage project deliverables and milestones.
- Identify critical to quality requirements with customer and development team.
- Meet financial objectives by reporting monthly and yearly forecast requirements.
- Troubleshoot new and existing product problems; recommends solutions.
- Train new program managers when necessary/delegated by Senior Program Manager.
- Work with minimal supervision and effectively communicate program requirements to internal and external customers.
- Work in conjunction with Business Development and Sales to maintain existing customer relationships and develops new business opportunities.
MINIMUM QUALIFICATIONS
Qualifications & Experience
- A demonstrated past of successful project and/or program execution (engineering environment favored).
- Experience in the medical device manufacturing environment preferred.
- Proficient with project management software; MS Project preferred.
- Thorough knowledge of Microsoft Office programs.
Education
- Four year (B.S. or B.A) degree with Business Administration, Technical, or Engineering emphasis preferred.
- Certification in Program Management (PMO) desirable.
Knowledge, Skills, & Abilities
- Ability to effectively prioritize and execute tasks in a high-pressure, high-stress environment (crucial).
- Knowledge of both theoretical and practical aspects/techniques/tools of program management; SCRUM experience favored.
- Robust interpersonal skills.
- Strong written and verbal communication skills.
- Mechanical ability; experience with calipers and other measuring equipment.
- Proven experience in people management, strategic planning, risk management, and change management.
- Detail oriented and accurate.
- Accountable, dependable, and adaptable personality characteristics.
- Ability to cohesively work with a group/team; ability to work as an individual.
- Decisive decision-making skills; strong delegation skills.