Reliability Engineer II (Design Quality Engineer)

Planet Pharma Group; Minneapolis (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Planet Pharma is seeking an experienced reliability engineer in Minnesota to lead design assurance, reliability testing, and quality activities for medical devices. Responsibilities include conducting reliability studies, performing DOE, and executing risk analyses to ensure regulatory compliance and product performance.

The role requires a bachelor’s degree and at least 2 years in quality or reliability within medical devices, plus ability to work with cross-functional teams and manage multiple

Qualifications

• Requires a Baccalaureate degree and minimum of 2 years of relevant experience.
• Experience in reliability engineering or quality in medical devices is expected.
• Familiar with design of experiments (DOE) and reliability testing methods.

Responsibilities

• Develops, coordinates and conducts technical reliability studies and DOE constructs.
• Recommends design or test methods and SPC procedures for reliability.
• Completes risk analysis studies of new design and processes.
• Analyzes performance reports and statistics; investigates variables affecting products and processes.
• Ensures corrective measures meet reliability standards and documentation is compliant.
• Develops reliability programs to meet objectives and may model failure risks.
• May determine units/batches requiring environmental testing and sample sizes.

Skills

Design Assurance/Design Quality/Reliab

General quality experience in med

Education

Bachelor's degree in a related field

Job description

Must Have

• Design Assurance/Design Quality/Reliability
• General quality experience in med device

Nice To Have

• Lean/six sigma experience
• self-driven, independent ability to engage with cross functional teams and manage multiple project workload

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 and that documentation is compliant with requirements.
• 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.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

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: 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 decision-making. 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 a Baccalaureate degree and minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience.