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Senior Manufacturing Engineer
2 months ago
We are seeking a highly skilled Senior Manufacturing Engineer to join our team at Element Science Inc. as part of our Medical Device Development department.
Key Responsibilities- Lead and support process development and validation activities across various manufacturing lines.
- Design, develop, test and implement manufacturing process systems to ensure robust production processes, human work factors, quality control and material flow.
- 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 into manufacturing, including support of R&D builds.
- Create, update, and maintain manufacturing documentation that meets compliance requirements.
- Interface with suppliers and key vendors on technical issues.
- Support manufacturing engineering efforts to meet production goals including resolution of non-conformances and line issues.
- Perform other duties, as needed.
- B.S. in Mechanical, Biomedical or Industrial Engineering preferred.
- Comprehensive SolidWorks knowledge with experience creating manufacturing fixtures, tooling and equipment models.
- Minimum 7 years of experience in medical device industry and electro-mechanical device manufacturing preferred.
- Experience with Lean/Six Sigma tools and proficiency with statistical methodologies acquired through formal training and/or direct work experience.
- 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.
- 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
