The client is seeking highly motivated and qualified candidates for the role of Manufacturing Engineer. In this role, you will be pivotal in bridging the gap between Product Development and Manufacturing to produce high-quality medical devices. You will contribute to the introduction of new products, cost reduction initiatives and the development of new processes required for manufacturing.
DUTIES/RESPONSIBILITIES:
- Perform all engineering elements of our Quality Management System, including:
- Design History Files (DHF)
- Device Master Records (DMR)
- 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.
The client provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.