- Provide Risk Management / Quality Engineering support to product development teams, helping to ensure development of highest quality new products.
- Develops quality procedures to address Risk Management requirements for new and existing products.
- Provides specific direction and support to address Risk Management requirements for active medical devices including programmable medical devices.
- Develops and implements product risk assessments for new products, or provides coaching and mentoring to product development team members to create risk assessments.
- Provides engineering support to operations engineering staff to remediate or update legacy product risk assessments.
- Responsible for developing Fault Tree Analysis for new or legacy products. Identifies and implements appropriate risk tools to facilitate identification and mitigation of product risks by applying body of knowledge/expertise and communicating to respective teams
- Provides formal training to new product development teams and operations staff regarding risk management processes, tools, and techniques.
- Provides direction and guidance to develop and implement quality management system procedures for risk management of active devices including programmable devices.
- Utilizes knowledge and experience of medical device design, manufacturing, and usage to help identify and mitigate device risks. Utilizes knowledge of Human Factors Engineering tools and techniques to identify and mitigate potential use errors.
Accountability / Scope
- Establishes and cultivates an extensive network of support to facilitate completion of assignments.
- Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel. May lead a project team. Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions. May interact with suppliers.;
- Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule. Establishes priorities of work assignments.;
- Exercises judgment in selecting innovative, practical methods to achieve problem resolution.
- Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
Education / Experience
- Bachelor's degree (Electric Engineering) plus 5-7 years of related work experience with a strong understanding of specified functional (ACTIVE DEVICES) area, or an equivalent combination of education and work experience.
- Advanced degree preferred.
- Wide application of technical principles, practices, and procedures.
- Strong understanding of business unit function and cross group dependencies/ relationships.
- Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
- Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
- Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of various technical alternatives and their impact.
OPEN TO RELOCATION
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