MDR – Product Engineer II – Exempt

Planet Pharma; Plymouth (MN); On-site; USD 70,000 - 95,000; Full time

Job summary

Planet Pharma is seeking a Manufacturing Process Engineer to design and optimize production layouts for the assembly of combination products that support cardiovascular therapies. This role emphasizes process design, testing methods, and cost-conscious production improvements.

You will drive SPC-based improvements, troubleshoot nonconforming product, lead problem solving teams using DMAIC, and ensure regulatory compliance. Strong communication and proficiency with JMP or Minitab are preferred.

Qualifications

• Bachelors in engineering with 2+ years of relevant experience, or advanced degree with 0 years.
• Experience applying DMAIC problem solving and leading teams.
• Strong communication skills and reporting to leadership.
• Proficiency with JMP or Minitab for statistics.
• Understanding of manufacturing processes for combination products.

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

DMAIC

Communication skills

Statistical software

Education

Bachelor's degree in engineering

Tools

JMP

Minitab

Job description

Responsibilities may include the following and other duties may be assigned:

• 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.

Must Have:

• Bachelor's degree in engineering (Mechanical, Biomedical, Chemical, or Industrial preferred), and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

Nice to Have:

• Operations/Manufacturing experience with desire to improve existing processes.


• Experience with problem solving methodologies (e.g. DMAIC) and ability to lead problem solving team.


• Effective communication skills (written and verbal) with experience reporting out to leadership.


• Experience with statistical software (JMP, Minitab).