Description: The Manufacturing or Sr. Manufacturing Engineer is pivotal in bridging the gap between Product Development and Manufacturing to produce high-quality medical devices. This role contributes to the introduction of new products, cost reduction initiatives and the development of new processes required for manufacturing.

DUTIES/RESPONSIBILITIES: 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. Requirements: This position requires the following qualifications (at a minimum):

Education Manufacturing Engineer: Engineering degree – Bachelor’s (BS) required or Associate’s (AS) with 2+ years’ experience in an engineering or related role. Engineering disciplines preferred: Mechanical, Manufacturing, Industrial, Biomedical Sr. Manufacturing Engineer: Engineering degree – Bachelor’s (BS) required Engineering disciplines preferred: Mechanical, Manufacturing, Industrial, Biomedical Master’s (MS) Degree preferred in above disciplines.

Experience Manufacturing Engineer A minimum of 3 years' experience in an engineering or related role. Sr. Manufacturing Engineer A minimum of 7 years’ experience in engineering or an engineering related role, with at least 3 years of that experience as a Manufacturing/Process Engineer. Medical device or orthopedics industry experience strongly 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 Experience 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 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. This position is an in-person role at our El Dorado Hills, CA headquarters. Interested? Please visit our careers website at https://shalbytech.com/careers for additional information.

We offer company holidays, vacation and sick time off, medical, dental, vision, disability and life benefits as well as a 401(k) Plan.

Shalby Advanced Technologies, Inc. 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. The expected base salary range for this position is between $95,000-$120,000 annually and the compensation offered will depend on the candidate’s qualifications.