Engineering Project Manager - Med Device Development (closed)
Effectively manage technical development projects and to provide expert guidance and support to the Madison site on project management to help achieve the business goals for new product introduction, quality, customer satisfaction, cost and safety.
This position may consist of additional expertise in any or all of the traditional engineering disciplines, i.e., (Quality, Mechanical, Electrical, Software, R&D, etc.)
Project Management - Facilitate the achievement of business goals through the development of excellent project management processes at the Madison site. Achievement of project goals for time, cost, product performance, quality and customer satisfaction in a team environment. Use of Critical Chain project management techniques and tools.
Identification, development, and accomplishment of key initiatives supporting the business objectives and Device Engineering goals for project management, management reporting, and resource management.
New product support -Product design to support ongoing development projects. Manage the component selection process to ensure product quality and reliability goals are achieved. Development of product specifications, design inputs and outputs, design verification, and process validation.
Regulatory compliance - Full awareness of existing SOP's and regulatory guidelines. Involvement to keep SOP's and processes current as improved business practices are implemented.
Ensure that product development projects are completed within time, cost, product performance and quality goals.
Providing leadership to other team member to ensure effectiveness and timeliness in meeting team goals.
To work on general project assignments and specific technical tasks received from development managers/site leaders
New product problem resolution.
Achieving goals by managing conflicting priorities requiring completion in a short timeframe.
Providing input into regulatory issues by interpreting guidelines and providing suggestions on how to comply.
Hazard and safety analysis.
Validation and verification process support.
Input and feedback regarding product design, design changes, and deviations having an impact on project deliverables.
Ikaria Madison is a device manufacturing and product design organization. Product specs and tolerances are tight and specific, quality demands are stringent.
Great emphasis is placed upon good financial performance, efficiency, and asset management. Systems are not configured with extensive mechanical and electronic testing.
Education 4 year degree in appropriate engineering discipline
Experience 2 -- 4 years + in medical device reliability product support
Special Skills/Abilities High degree of interpersonal, influencing skills, negotiation and team skills. High degree of skills in statistical reliability modeling. High degree of project coordination skills. Complex problem solving skills. In depth understanding of cGMP requirements, ISO 13485 and other regulatory requirements..
Ikaria is an equal opportunity employer. Applicants receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability, veteran status, pregnancy, sexual orientation, gender identity, or membership in any other class protected by applicable federal, state, local or foreign anti-discrimination laws.