Sr. Product Development Engineer

As a Senior 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, coordination of mechanical testing as required, and product launch to domestic and international markets. You will also provide leadership within the engineering department for implantation best practices, competing products and procedures during product development phases, and providing guidance to other engineers.

Qualifications

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

• Engineering degree – Bachelor’s (BS) or Master’s (MS) Degree in Mechanical, Biomedical, or Biomechanical

Experience

• 5+ years minimum experience in engineering or engineering related role.
• 2+ years direct engineering experience class I/II orthopedic instruments and medical device implants.
• Product Development Engineering
• Experience with standard industry or medical device regulated quality management system (ISO 13485, 21 CFR 820, 21CFR 11, FDA Regulations, ISO 9001, CE Marking).
• Product Design – Experience leading or supporting engineering design projects in a fast-paced environment.
• Computer Aided Design – Proficiency in SolidWorks and 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 developing product through all five phases of Design Controls including design control documentation, product development, product verification and validation testing, and release to domestic and/or international markets.
• Strong analytical and problem-solving skills.
• Strong organizational skills.
• Strong MS Office skills (Excel, Word, PowerPoint, Outlook).

Preferred Requirements

• Experience working in manufacturing and quality inspection environment.
• Experience working with domestic and international suppliers and supply chains.
• Experience in project management
• Product Data Management (PDM) – Experience with SolidWorks PDM.
• Material Requirements Planning (MRP) – Experience with Syspro or equivalent MRP software

Skills & Attributes

• Ability to work accurately and efficiently to complete assigned tasks.
• Prioritize patient clinical outcomes and surgeon satisfaction as highest priority, and subordinately balance all other objectives responsibly and ethically.
• Ability to continuously learn and develop engineering skills.
• Ability to comprehend, follow, and implement FDA regulations and 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.
• Ability to maintain accurate records and files, both paper and electronic
• 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.

DUTIES/RESPONSIBILITIES:

• Perform all engineering elements of our Quality Management System, including:
  • Design Controls (Phases 1 – 5)
  • Risk Analyses, DFMEA
  • Design History Files (DHF)
  • Device Master Records (DMR)
  • Design Transfer
  • 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.

• Provide leadership, technical insight, and training other engineers within the engineering department

Job Type

Full-time

Pay

Negotiable

Benefits

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Paid time off
• Vision insurance

Schedule

• 1st shift
• Monday to Friday

Education

• Bachelor’s (Required)

Work Location

El Dorado Hills, CA, USA