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Reliability Engineer II
8200 Coral Sea Street Northeast Mounds View, MN 55112 US
Job Description
Additional position details from the manager below:
- Can you please confirm your top 3 skills sets required? – Risk Management, Trending, Good Documentation Practices
- Can you please confirm the 3 main responsibilities/day to day activities required for this role? – Complaint trending, Risk document updates, Supporting Change orders
- What products (if any) will this role support? Cannula
- What is your target years of experience? 3-4
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TECHNICAL SKILLS
Must Have
1. Experience in handling complaint management
2. Good Technical writing skills – The candidate will write complaint summaries, investigation, and analysis summaries on the complaints.
3. Good communication skills
• 1+ years of experience in Complaint handling or customer service/technical support experience
Nice To Have
- 1. Change control of Medical Devices
- 2. Equipment Commissioning / Qualification
- 3. Process Validation
- 4. Computer System Validation (CSV)
- 5. Manufacturing, Packaging and Laboratory Equipment
- 6. Technical experience (Trouble shooting) or any similar experience or background
- 7. Quality / Process Control / Assurance of Medical Devices
- 3+ years of experience in the medical device industry, with a strong background in Non -Conforming Materials Reports (NCMR), CAPA, or product quality management.
- Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
- Proven experience leading NCMR and CAPA processes, ideally within a medical device or regulated industry.
- Strong project management skills, with the ability to manage multiple priorities and deadlines.
- Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions.
- Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders.
- Proficiency in Microsoft Office Suite and quality management systems (QMS). Strong technical writing capability.
- Experience in Process Validation.
Responsibilities may include the following and other duties may be assigned. Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs. Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability. Completes risk analysis studies of new design and processes. Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes. Ensures that corrective measures meet acceptable reliability standards. Analyzes preliminary plans and develops 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. As necessary, proposes changes in design or formulation to improve system and/or process reliability. May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.
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
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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