Prin R-D Engineer – Medical Device

Job Title: Prin R-D Engineer – Medical Device

Job Location: Tempe, Arizona (Fully Onsite)

Type: W2 contract

Duration: 4 Months (Possible for ext)

Technical skills that are required for the role:

1. Process development (i.e., process characterization and validation – DOE, PCR, TMV, IQ, OQ, PQ)

2. Statistics

3. Strong problem-solving skills

Education Required: Advanced degree in Physics, Mechanical Engineering, Materials Science, Chemistry, Chemical Engineering, Biomedical Engineering, or similar discipline. Years’ Experience Required: 5 years

Lead the innovation, development, and/or optimization of new manufacturing concepts, processes, and procedures for transfer to manufacturing operations.

Champion the use of Design for Reliability and Manufacturing (DRM) and data-driven methods through process development

Work with process owners and product development teams to define robust process flows for new products

Work with technology development to understand new process technologies for research and development towards release to manufacturing operations.

Own requirements flow down from product design to process development, including working with process owners to disposition inputs/outputs to deliver efficient, cost-effective, and robust control and monitor strategies

Own equipment scouting, down selection, qualification, and characterization.

Own process characterization and process validation activities to ensure the maturity and stability of processes when released to manufacturing. (DOE, TMV/Gage R&R, IQ, OQ, PQ, etc)

Own the interfaces and interactions between processes and determine product integration risks

Lead risk assessments and risk burn-down activities for process interfaces and interactions

Provide input into product and process design based on an understanding of the integration risks

Applies statistical methods and science-based decisions to design experiments and implement improvements

Coordinate and/or perform necessary experiments and product builds to establish robust processes

Implement and own yield monitoring systems and procedures for equipment and processes developed

Monitor, root cause, and resolve process yield issues during product and process development

Lead the identification and implementation of corrective actions for yield issues in collaboration with process owners and product engineers

Reviews product development requirements for compatibility with processing methods to determine costs and schedules

Interacts with product design and development personnel to ensure that processes and designs are compatible

Generates and maintains documentation per quality system regulations

Ensures processes and procedures comply with regulations

Responsibilities may include the following, and other duties may be assigned.

Designs, develops, analyzes, troubleshoots, and provides technical skills during research and/or product development. Designs studies to investigate specific life science questions within the field of expertise. May be involved in product research and development and/or clinical trials. Translates research discoveries into usable and marketable products.

Specialist Career Stream: Typically, an individual contributor with responsibility in a professional discipline or specialty. 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 and overseeing the projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically a University).

Differentiating Factors Autonomy: Recognized expert, managing large projects or processes. Exercises considerable latitude in determining deliverables of assignments, with limited oversight from the manager. Coaches, reviews, and delegates work with lower-level specialists. Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. May manage large projects or processes that span outside of the immediate job area. Innovation and Complexity: Problems and issues faced are difficult, moderately complex, and undefined, and require detailed information gathering, analysis, and investigation. Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance the performance of the job area. Implements solutions to problems. Communication and Influence: Represents the organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. May negotiate with others to reach an understanding or agreement, and influence decision-making. Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within the job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.

Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience, or an advanced degree with a minimum of 5 years of relevant experience.