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MDR - Prin R-D Engineer
2343 West Medtronic Way Tempe, AZ 85281 US
Job Description
Top 3 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 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 are in compliance 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 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 and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
DIFFERENTIATING FACTORS
Autonomy: Recognized expert, managing large projects or processes . Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager . Coaches, reviews and delegates work to 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 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 performance of job area. Implements solutions to problems.
Communication and Influence: Represents 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 understanding or agreement, and influence decisionmaking.
Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within 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 advanced degree with a minimum of 5 years of relevant experience.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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