Manufacturing Engineer (Medical Device)

This Jobot Job is hosted by: Emily OlingerAre you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary: $100,000 - $130,000 per year

• Full Medical, Vision, and Dental (PPO and HMO)
• Bonus program
• 401k matching
• FSA, Pet Insurance, Life Insurance, AD&D Insurance
• PTO and all major holidays
• 529 College Savings Plan
• Discounts at partnered retailers (gym, phones, etc.)

• Take ownership of new products during pilot production phase through successful and sustained project launch. This includes but is not limited to driving new product introduction schedules, escalating and resolving manufacturability issues.
• Design, qualify, document, and introduce production and service assembly/test fixtures and equipment.
• Configure assembly processes, sequence of activities, and material handling toward lean manufacturing practices, supporting company goals.
• Conduct testing, utilizing new or existing test protocols, to ensure process capability.
• Develop test plans and procedures dealing with the material acquisition and substitution problems, as well as technical issues impacting shipments.
• Oversee the detailed manufacturing planning for each part and assembly. Specify BOM structure, methods, sequence of operations, shop routing, time standards, and tooling as required.
• Optimize manufacturing costs, determine time standards, and make recommendations for tooling and process requirements of new or existing product lines.
• Ensure product development plan is complete and properly implemented, ensuring manufacturing resources are properly directed during the entire product life cycle.
• Recommend and report on production process improvements including efficiency, cycle time, downtime, first-pass yield, resource utilization, ergonomic, and other continuous improvement efforts.
• Understand, follow and support our internal Quality System policies, procedures and work instructions including but not limited to applicable external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations and applicable International Standards).

• Thorough knowledge of manufacturing processes and materials. Experience in the medical device industry is strongly preferred.
• Demonstrated Electromechanical and/or Process Engineering capability.
• Successful working knowledge and experience writing protocols, running tests, and documenting results.
• Familiar with a 3D solid modeling package, preferably Solid Works, Solid Edge, and AutoCad software.
• Ability to drive and influence cross-functional teams working on manufacturability and new product release projects relative to cost reduction, product redesign, and manufacturing quality.
• Knowledge and experience with Lean Manufacturing concepts.
• Ability to travel domestically, as needed, to support supplier audits and other business needs, as necessary. Able to travel to vendor sites as required by management.