Medical Device Process Engineer II — Regulatory Focus

Planet Pharma; Plymouth (MN); On-site; USD 70,000 - 100,000; Full time

Job summary

Planet Pharma in Minnesota seeks a Manufacturing Process Engineer to design and optimize production layouts for cardiovascular combination products. You will support testing methods, tooling, and yield improvements while ensuring compliance with regulatory requirements.

Responsibilities include reducing scrap, dispositioning nonconforming product, maintaining SPC-driven processes, and guiding design and production procedures.

Qualifications

• Bachelor's degree in engineering and 2+ years related experience.
• Advanced degree with 0 years experience preferred.
• Experience with problem-solving methodologies (DMAIC) and data-driven decisions is valued.
• Experience reporting out to leadership is beneficial.

Responsibilities

• Designs manufacturing processes, procedures and production layouts for the assembly of combination products that support cardiovascular therapies.
• Responsible for production support engineering with respect to testing methods, procedures, and problems; device specification and yield problems; minor redesign of devices and masks; analysis of customer returns; and optimizing device production relative to cost constraints.
• Identifies and implements improvements to reduce production scrap.
• Investigates and dispositions nonconforming product.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Develops and maintains manufacturing processes through the use of statistical process control.
• Provides guidance regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Designs sequence of operations and specifies procedures for product manufacture.
• Ensures processes and procedures are in compliance with regulations.

Skills

Problem solving

Communication skills

DMAIC Experience

Education

Bachelor's degree in Engineering (Mechanical/ Biomedical/ Chemical/ Industrial)

Advanced degree (MS/PhD) with 0 years experience

Tools

JMP

Minitab

Job description

Planet Pharma in Minnesota seeks a Manufacturing Process Engineer to design and optimize production layouts for cardiovascular combination products. You will support testing methods, tooling, and yield improvements while ensuring compliance with regulatory requirements.

Responsibilities include reducing scrap, dispositioning nonconforming product, maintaining SPC-driven processes, and guiding design and production procedures.