Reliability Engineer II - Exempt

Lancesoft; Minneapolis (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Lancesoft in Minneapolis, MN seeks a dedicated Reliability Engineer to join our quality and reliability engineering team. You will contribute to the development of cutting-edge medical device technologies and ensure product reliability through design QA and statistical methods.

Requires a baccalaureate degree with at least 2 years of relevant experience; Master’s degree is a plus. Lean/Six Sigma experience is preferred, and you’ll collaborate with cross-functional teams on multiple projects.

Qualifications

• Requires a Baccalaureate degree and minimum 2 years of relevant experience.
• Experience in medical device quality and reliability is preferred.
• Lean/Six Sigma experience is a plus.

Responsibilities

• Develop reliability studies and DOE constructs.
• Recommend design/test methods and SPC procedures.
• Complete risk analyses for new designs.
• Analyze performance data and control statistics.
• Ensure documentation meets requirements.
• Develop reliability programs to meet objectives.
• Create mathematical models to identify high-risk units.
• Propose design changes to improve reliability.
• Determine units for environmental testing and sampling.
• Specialize in design, materials, production control, QA areas as needed.
• Develop and maintain quality standards for processing materials.
• Collaborate with engineering and manufacturing to ensure standards.
• Design inspection/testing mechanisms and perform statistical analysis.

Skills

Design Assurance

Design Quality

Reliability

Quality Systems

DOE

Statistical Process Control

Risk Analysis

Cross-functional collaboration

Lean Six Sigma

Education

Bachelor's degree in a relevant field

Master's degree in a relevant field

Job description

Join our team in Minneapolis, MN, where you'll have the opportunity to work in a dynamic environment at the forefront of medical device innovation. As a key player in our quality and reliability engineering team, you'll contribute to the development of cutting-edge technologies and therapies.

Must Have Design Assurance/Design Quality/Reliability General quality experience in medical devices

Nice to Have Lean/Six Sigma experience Self-driven, with the ability to engage with cross-functional teams and manage multiple project workloads

Responsibilities

• Develop, coordinate, and conduct technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
• Recommend design or test methods and statistical process control procedures for achieving required levels of product reliability.
• Complete risk analysis studies of new design and processes.
• Compile and analyze performance reports and process control statistics;investigate and analyze relevant variables potentially affecting product and processes.
• Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• Analyze preliminary plans and develop reliability engineering programs to achieve company, customer, and governmental agency reliability objectives.
• Develop mathematical models to identify units, batches, or processes posing excessive failure risks, if necessary.
• Propose changes in design or formulation to improve system and/or process reliability.
• Determine units and/or batches requiring environmental testing, and specify the minimum number of samples to obtain statistically valid data.
• Specialize in areas such as design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality.
• Develop, modify, and apply, and maintain quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
• Design or specify inspection and testing mechanisms and equipment;conduct quality assurance tests;and perform 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 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 a 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 the effectiveness of the 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 to inform, gain input, and support decision-making.
• Leadership and Talent Management: May provide guidance and assistance to entry-level professionals and/or employees in the Support Career Stream.

Required Knowledge and Experience

Requires a Baccalaureate degree and a minimum of 2 years of relevant experience OR a Master's degree with a minimum of 0 years of relevant experience.