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Reliability Engineer II (Design Assurance Engineer II)
Brooklyn Park, MN Minneapolis, MN 55428 US
Job Description
Can you please confirm your top 3 skills sets required?
- Detail oriented
- Collaborative
- Critical Thinking
- Can you please confirm the 3 main responsibilities/day to day activities required for this role?
- TMV Execution/Design Verification Support
- Project Document Reviews as the Quality Representative
- Data Analysis – Minitab experience, confidence intervals, hypothesis testing
· Navigates the complexity of government and industry regulations to include 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, European Union (EU) Medical Device Regulation (MDR), ISO 14971.
· Ensure Design Quality Assurance-driven initiatives meet objectives in delivering highest quality products, with supporting tools and processes.
· Acts as a collaborative effective leader or team member in supporting quality disciplines, decisions, and practices.
· Develop and/or support the development of risk management architecture, support Design for Reliability and Manufacturability (DRM) targets, support design and phase reviews, support design transfer.
· Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.
· Develops overall operating criteria to ensure implementation of the quality program according to project, process and contract requirements and objectives, and ensures compliance of projects and related documents with requirements and standards.
· Reviews design, change specifications, and plans against contractual and/or process requirements.
· Reviews include applicable specifications, materials, tools, techniques, and methodologies.
· Provides or directs verification of device requirements, traceability, and testability.
· Recommends and implements design or test methods for achieving required levels of product reliability.
· Plans and leads test method validation of design verification methods. Responsible for design verification planning and execution. Responsible for verifying product and software performance meets design requirements. Utilizes statistical analysis tools to analyze data, such as Analysis of Variance (ANOVA), Gage Repeatability and Reproducibility (Gage R&R), Attribute Agreement Analysis and Test Method Validation (TMV). Completes reports.
· Completes risk management files of new design and updates to released products.
· Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification, and validation.
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: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.
Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking.
Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
Required Knowledge and Experience:
Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of 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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