Product Development Engineer

Shalby Advanced Technologies•El Dorado Hills, CA

2d•$85,000 - $105,000•Onsite

About The Position

This position is an in-person role at our El Dorado Hills, CA headquarters. Interested? Please visit our careers website at shalbytech.com/careers for additional information. As a Product Development Engineer, your role will be to creatively address project related design issues and lead development feasibility/concept work on new development projects. You will be responsible for the design conceptualization of new product ideas; creative problem solving; and facilitation of product development activities such as design and coordination of prototypes, evaluation of new concepts, solid modeling and drafting, participation in brainstorming and other team activities, and coordination of mechanical testing as required.

Requirements

Engineering degree – Bachelor’s (BS) or Master’s (MS) Degree in Mechanical, Biomedical, or Biomechanical preferred.
Experience 5+ years minimum experience in engineering or engineering related role.
Product Design - Experience leading or supporting engineering design projects in a fast-paced environment.
Computer Aided Design – Proficiency in SolidWorks, Pro/Engineer (Creo) preferred. Other computer aided design software packages will be considered.
Experience building 3D CAD parts, assemblies, manufacturing drawings, and bill of materials
Experience implementing Geometric Dimensioning and Tolerancing (GD&T) per ASME Y14.5.
Experience processing Engineering Change Orders (ECO, ECN, ECR, or CRN’s)
Experience with standard industry or medical device regulated quality management system (ISO 9001, ISO 13485, 21 CFR 820).
Strong analytical and problem-solving skills.
Strong organizational skills.
Strong MS Office skills (Excel, Word, PowerPoint, Outlook).

Nice To Haves

2+ years direct engineering experience class I/II orthopedic instruments and medical device implants.
Experience working in manufacturing and quality inspection environment.
Product Data Management (PDM) – Experience with SolidWorks PDM.
Material Requirements Planning (MRP) - Experience with Syspro or equivalent MRP software.
Prior experience working in the medical device or orthopedics industry.

Responsibilities

Perform all engineering elements of our Quality Management System, including:
Design Controls
Risk Analyses, DFMEA
Design History Files (DHF)
Device Master Records (DMR)
Engineering Change Notices
New product development
Evaluate design feasibility of new product ideas and use design control processes to develop new product designs from concept to commercialization.
Develop product line extensions, changes, upgrades, and rework
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.