- Acts as an individual contributor, core team or technical lead for a specific project.
- Accountable for the completion of assigned deliverables in accordance with approved schedules.
- Authors documentation and participates in activities in support of design control.
- Independently plans, performs & prioritizes tasks that are complex in nature, in alignment with corporate goals.
- Analyzes and interprets data, identifying trends and formulating the next steps, while effectively performing trade off analysis, if required by the function.
- Leads, designs and/or develops one or more of the following: new test methods, specifications, technical apparatus, software and processes for complex components and functions.
- Identifies product defects and recognizes outliers in results. Able to explain and document product defects and their impact.
- Effectively communicates technical information to a multidisciplinary team in the form of documentation, presentations and technical summaries and promotes collaboration.
- Technical expertise in a least 1 area and emerging as a subject matter expert.
- Provides technical guidance to and/or supervision of other group members and cross-functional technical teams. Able to mentor others.
- Provides technical support for or leads CAPA or complaint investigations.
- Independently generates predictable schedules for activities related to the function, understanding cross-functional dependencies.
- May review and provide input to deliverables from other functions.
- Recommends and leads implementation of improvement initiatives to aid department practices.
- May be assigned CAPA ownership.
Minimum Knowledge & Experience Required for the Position:
- Bachelor's degree in Engineering, Science or a related field
- Ten years of product development or relevant experience
- Six to eight years of product development or relevant experience for advanced degrees
- For internal candidate promotion: Demonstrated proficiency in meeting all competencies of current level and acceptable performance history may be used in lieu of experience
- In vitro medical device experience highly desired.
- Additional Skills/Knowledge:
- Language: Proficiency in English language required.