Manufacturing Engineer

DUTIES/RESPONSIBILITIES:

Perform all engineering elements of our Quality Management System, including:

1. Design Controls
2. Risk Analyses, DFMEA
3. Design History Files (DHF)
4. Device Master Records (DMR)
5. Engineering Change Notices

• Develop product line extensions, changes, upgrades, rework and end-of-life activities
• Maintain existing product segments in accordance with company and industry standards.
• Design Verification and validation activities

Testing protocols, data collection, data analysis, and technical report preparation.

• Manage transfer to manufacturing, including vendor support.
• Provide support to Clinical and Regulatory Affairs for submissions and responses to FDA.
• Other duties specifically assigned by management.

This position requires the following qualifications (at a minimum):

• Mechanical Engineering degree – Bachelor’s (BS) required, or Master’s (MS) Degree preferred.

Experience:

• A minimum of 3 years' experience in engineering or an engineering related role. Medical device or orthopedics industry experience preferred.
• Experience with supporting production released products, cost reduction activities and driving process improvements.
• Good understanding of machining processes – CNC Machining, additive manufacturing, Metal & plastic finishing
• Experience using various medical grade materials – Cobalt Chrome, Titanium, Stainless Steel, Plastics
• Hands-on experience implementing GD&T, implementing engineering changes.
• Thorough understanding of Design for Manufacturability and a proven history of using DFM tools to drive design change.
• Experience with ISO 13485, 21 CFR 820

Preferred Requirements:

• Direct engineering experience with class I/II orthopedic instruments and medical device implants
• Proficiency in SolidWorks and/or Pro/Engineer (Creo) preferred Product Data Management (PDM) – Experience with SolidWorks PDM.
• Material Requirements Planning (MRP) - Experience with Syspro or equivalent MRP software.

Skills & Attributes:

• Act as a technical liaison between R&D Engineering, Manufacturing & Supply Chain
• Collaborate with design engineering to coordinate the release of new products, conduct investigations, identify corrective and preventive actions, and support material disposition in collaboration with the Quality group.
• Coordinate with the appropriate suppliers in developing & implementing cost reduction initiatives and process improvement plans.
• Design, develop, construct, and implement tools, fixtures, and gauges. Perform equipment qualifications.
• Drive continuous improvement initiatives to improve manufacturing processes, reduce waste, and improve product quality and reliability.
• Support the transfer of manufacturing processes and products to internal or external manufacturing sites, including validation activities and process documentation.
• Support a wide variety of processing applications such as machining, finishing, forging, casting, cleaning, heat treating, bonding, molding, etc.
• Maintain and improve controlled technical documents such as prints, procedures, bill of materials and routers
• Participate in internal and external audits and inspections, providing documentation and support as needed to demonstrate compliance with regulatory requirements and quality standards.
• Prioritize patient clinical outcomes and surgeon satisfaction as highest priority, and subordinately balance all other objectives responsibly and ethically.
• Ability to work accurately and efficiently to complete assigned tasks.
• Ability to comprehend, follow, and implement regulations & guidelines.
• Ability to work independently without direct supervision, and collaboratively.
• Self-starting, self-directed, and highly motivated.
• Ability to challenge opinions and decisions of management and executive teams when needed.
• Willingness to wear multiple hats as required.
• Excellent verbal, written, typing, computer, and presentation skills.
• Ability to work and communicate with employees, management, and outside parties in a respectful, open, honest, and professional manner.
• Willingness to help build and maintain a healthy corporate culture.