Product Development Engineer

Job Description

Job DescriptionDescription:

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.

Duties/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.

Requirements:

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

• 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).

Preferred Experience

• 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.

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: age, genetic information/characteristics, marital status, medical condition, mental or physical disability, national origin and ancestry, pregnancy and perceived pregnancy, race and color, religion, sex/gender including pregnancy, breastfeeding, gender identity or gender expression, sexual stereotypes, sexual orientation, reproductive health decision-making and veteran or military status.

The expected base salary range for this position is between $85,000 to $105,000 annually and the compensation offered will depend on the candidate’s qualifications.