Job description

Join our team in Mounds View, MN, a vibrant and dynamic location that offers a perfect blend of professional opportunities and a great quality of life. We are looking for a dedicated professional to contribute to our mission of delivering innovative solutions in the medical device industry. Must Have • Previous experience with Quality Systems, CAPA, Change Control, and Validations • Knowledgeable on Medical Device Regulatory Requirements • Experience with Quality & Regulatory Audit activities Key Responsibilities • Develop, coordinate, and conduct technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs. • Recommend design or test methods and statistical process control procedures for achieving required levels of product reliability. • Complete risk analysis studies of new designs and processes. • Compile and analyze performance reports and process control statistics; investigate and analyze relevant variables potentially affecting product and processes. • Ensure that corrective measures meet acceptable reliability standards. • Analyze preliminary plans and develop reliability engineering programs to achieve company, customer, and governmental agency reliability objectives. • May develop mathematical models to identify units, batches, or processes posing excessive failure risks. • Propose changes in design or formulation to improve system and/or process reliability as necessary. • Determine units and/or batches requiring environmental testing, and specify a minimum number of samples to obtain statistically valid data. Technical Specialist Career Stream An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers, and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering R&D, systems, or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills. Differentiating Factors • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop an approach to solutions. Coaches and reviews the work of lower-level specialists; may manage projects/processes. • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. • Innovation and Complexity: Problems and issues faced are difficult and may require understanding of multiple issues, job areas, or specialties. Makes improvements of processes, systems, or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements. • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchanges information of facts, statuses, ideas, and issues to achieve objectives and influence decision-making. • Leadership and Talent Management: May provide guidance, coaching, and training to other employees within the job area. May manage projects, requiring delegation of work and review of others' work product. Required Knowledge and Experience • Baccalaureate degree with a minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years of relevant experience OR PhD with 0 years of relevant experience.

Requirements

Must-haves

Previous experience with Quality Systems, CAPA, Change Control, and Validations
Knowledgeable on Medical Device Regulatory Requirements
Experience with Quality & Regulatory Audit activities
Develop, coordinate, and conduct technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
Recommend design or test methods and statistical process control procedures for achieving required levels of product reliability.
Complete risk analysis studies of new designs and processes.
Compile and analyze performance reports and process control statistics; investigate and analyze relevant variables potentially affecting product and processes.
Ensure that corrective measures meet acceptable reliability standards.
Analyze preliminary plans and develop reliability engineering programs to achieve company, customer, and governmental agency reliability objectives.
May develop mathematical models to identify units, batches, or processes posing excessive failure risks.
Propose changes in design or formulation to improve system and/or process reliability as necessary.
Determine units and/or batches requiring environmental testing, and specify a minimum number of samples to obtain statistically valid data.
Technical Specialist Career Stream
Differentiating Factors
Communication and Influence: Communicates with senior internal and external customers and vendors. Exchanges information of facts, statuses, ideas, and issues to achieve objectives and influence decision-making.
Leadership and Talent Management: May provide guidance, coaching, and training to other employees within the job area. May manage projects, requiring delegation of work and review of others' work product.
Required Knowledge and Experience
Baccalaureate degree with a minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years of relevant experience OR PhD with 0 years of relevant experience.

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Effort: medium

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