Design Assurance Engineer - Medical Device

Planet Pharma; Minneapolis (MN); Sur place; USD 65 000 - 90 000; Plein temps

Résumé du poste

Planet Pharma is seeking a junior Design Assurance Engineer in Minneapolis to support reliability testing and quality program development. The role involves coordinating design quality activities with cross-functional teams to ensure compliant documentation and robust product reliability.

The candidate will contribute to reliability studies, DOE concepts, and risk analyses while supporting process improvements across design and manufacturing functions.

Qualifications

• 2 years of experience in the medical device industry
• Bachelor's degree in engineering
• Familiarity with design quality systems and reliability testing

Responsabilités

• Develops reliability studies and DOE constructs.
• Recommends design or test methods and SPC procedures for reliability.
• Completes risk analysis studies of new design and processes.
• Compiles and analyzes performance reports and process control statistics.
• Ensures corrective measures meet reliability standards and documentation is compliant.
• Develops reliability programs to meet objectives.
• May develop mathematical models to identify high-risk units or processes.
• Collaborates with engineering and manufacturing to ensure quality standards.

Connaissances

Design Assurance/Design Quality/Reliab

Quality in medical devices

Cross-functional teamwork & workload

Formation

Bachelor's Degree in Engineering

Description du poste

Our client, a leading Medical Device company, is seeking a junior level Design Assurance Engineer for their growing team in Minneapolis. See below for additional details!

Skills Needed:

• Design Assurance/Design Quality/Reliability
• General quality experience in medical devices
• Self-driven, independent ability to engage with cross functional teams and manage multiple project workload

Responsibilities:

• 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.

Requirements:

• 2 years of experience within the medical device industry
• Bachelor's Degree within an Engineering realm