Staff Manufacturing Engineer

Element Science

$150K — $170K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • B.S. in Mechanical, Biomedical or Industrial Engineering preferred
  • Comprehensive SolidWorks knowledge; experience in manufacturing fixtures and equipment models
  • Minimum 10 years of experience in the medical device and electro-mechanical manufacturing industry
  • Experience with Lean/Six Sigma tools and statistical methodologies
  • Demonstrated ability to navigate regulated environments
  • Strong problem-solving skills and decision-making abilities

Responsibilities

  • Support process development and validation across manufacturing product lines
  • Design and implement manufacturing process systems for quality control
  • Propose improvements for processes and equipment using engineering principles
  • Utilize six sigma tools for root cause analysis and corrective action development
  • Transfer new products and processes into manufacturing
  • Maintain compliance documentation for manufacturing processes
  • Collaborate with vendors to resolve technical production issues

Benefits

  • Stock Options
  • 90% employer-paid medical, dental, and vision insurance
  • Company-paid Basic Life Insurance
  • 401(k) retirement plan (Traditional and Roth)
  • Competitive Paid Time Off
  • Paid Holidays
  • Flexible Spending Accounts (FSA)
  • Health Savings Account (HSA)
  • Employee Assistance Program through PEO
Full Job Description
SUMMARY OF ROLE:

Staff Manufacturing Engineer drives and provides support of products, processes, and equipment to achieve development and/or production goals. The engineer develops manufacturing processes to implement innovative improvements. The engineer works cross-functionally to validate processes and transfer new products into manufacturing.

RESPONSIBILITIES:
  • Support process development and validation activities across various manufacturing product lines
  • Design, develop, test and implement manufacturing process systems to ensure robust production processes, human work factors and quality control
  • Design, develop and propose improvements for manufacturing process, equipment and systems using knowledge of engineering principles, industry standards and working design to meet production requirements, performance, quality, and safety standards
  • Employ six sigma tools and scientific and statistical expertise to perform root cause and correlation analysis to identify and develop corrective actions for solving product and process failures
  • Transfer new products & processes into manufacturing, including support of R&D builds
  • Create, update, and maintain manufacturing documentation that meets compliance requirements
  • Partner with outsourced vendors and suppliers to support production and resolve technical issues, working closely with MPI to establish and onboard new vendors
  • Support manufacturing engineering efforts to meet production goals including resolution of non-conformances and line issues
  • Perform other duties, as assigned

QUALIFICATIONS:
  • B.S. in Mechanical, Biomedical or Industrial Engineering preferred
  • Comprehensive SolidWorks knowledge with experience creating manufacturing fixtures, tooling, and equipment models
  • Minimum 10 years of experience in medical device industry and electro-mechanical device manufacturing preferred
  • Experience with Lean/Six Sigma tools and proficiency with statistical methodologies preferred
  • Demonstrated technical acumen in navigating regulated environments
  • Excellent interpersonal, writing, and verbal communication skills
  • Demonstrated ability to balance multiple priorities against aggressive deadlines while maintaining a high degree of quality
  • Strong judgment & decision-making ability
  • Excellent problem-solving skills, ability to diagnose issues and provide solutions
  • Experience with adhesives and electronics preferred and background with medical device disposables and capital equipment a plus
  • Strong technical expertise with manufacturing processes, automation, and materials

BENEFITS:

Element Science offers a very competitive salary and benefits package including, but not limited to:
  • Stock Options
  • 90% employer-paid medical, dental, and vision insurance
  • Company-paid Basic Life Insurance
  • 401(k) retirement plan (Traditional and Roth)
  • Competitive Paid Time Off
  • Paid Holidays
  • FSA (Flexible Spending Accounts)
  • HSA (Health Savings Account)
  • Employee Assistance Program through PEO

The salary for this exempt-level position will be based on experience and qualifications within an established pay range.
  • Pay range: $150,000 - $170,000

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