Process Development Engineer

Responsibilities

• Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development.
• Designs studies to investigate specific life science questions within field of expertise.
• May be involved in product research and development and/or clinical trials.
• Translates research discoveries into usable and marketable products.

Requirements

• Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
• Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
• Experience in validation and performance analysis (MSA, IQ/OQ/PQ, TMV) ensuring regulatory compliance and reliability.
• Experience with DRM / DFSS, Lean Sigma, or Green/Black Belt Lean Sigma certification.
• Experience with Process Validation and Computer software validation knowledge.
• DFSS Green Belt Certification, DRM Green Belt certificate.

Qualifications

• Advanced degree in Physics, Mechanical Engineering, Materials Science, Chemistry, Chemical Engineering, Biomedical Engineering or similar discipline.
• 5 years of relevant experience.

Specialist Career Stream

• Typical individual contributor with responsibility in a professional discipline or specialty.
• 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.

Benefits

ACA-compliant supplemental package available for enrollment.

Pay: $50.00 - $65.00/hr; W2 contract, no PTO, no Benefits.

Schedule

Medical device process development and manufacturing, experience of products with electrical functionality an advantage.

Shift

Examples of critical thinking and use of statistics
Working in a cross functional teams and leveraging basic PM skills e.g. project planning, communication, risk management, etc.
Engage with team to understand goals and current reality, provide solutions and align on path forward, drive/track/communicate progress, adapt as needed with team.

Start

Investigation and root cause analysis skills
Investigation and root cause analysis skills
Technical writing knowledge
Organization and Communication skills
Process Validation and Computer software validation knowledge
DFSS Green Belt Certification
DRM Green Belt certificate

Education

• Advanced degree in Physics, Mechanical Engineering, Materials Science, Chemistry, Chemical Engineering, Biomedical Engineering or similar discipline.

Years' Experience

• 5 years.