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About the Role

The Product Development Engineer executes New Product Development for surgical implants, prosthetics, and instruments, covering Concept Development, Design & Development, Design Verification & Validation, and Design Transfer to production. This role involves serving as a core team member of the Design Engineering team and partnering with cross-functional experts.

Responsibilities

• Generate product development documentation ensuring compliance with internal operating procedures, ISO 13485 and FDA 21CFR Part 820.30.
• Conduct risk management activities (FMEA) and document results ensuring compliance with internal procedures and ISO-14971.
• Conduct biocompatibility and sterilization evaluations and generate documentation ensuring compliance with internal procedures, ISO 10993-1 and ISO 11737.
• Perform Finite Element Analysis if needed.
• Perform statistical analysis for test results and sample size rationalization.
• Review dimensions of parts, materials to be used, relations of one part to another, and relation of various parts to whole structure of product lines.
• Review and approve drawings, applying knowledge and experience utilizing Geometric Dimensioning & Tolerancing (GD&T) per ASME Y14.5
• Develop engineering protocols/reports, initiates Change Orders (CO) and prepare engineering documentation.
• Assist in project activities to coordinate new product introductions.
• Coordinate with vendors and other project participants to ensure timely response to action items.
• Participate in the planning and execution of Design Verification & Validation activities.
• Participate in activities including product & packaging performance evaluation, Biocompatibility assessments, Usability Studies and Sterilization Validation assessment.

Requirements

• Proficient in 3D CAD modeling and Engineering Drawings (SolidWorks or similar).
• Strong technical writing skills and experience writing product requirements, specifications, test protocols and test reports, and engineering rationales.

Skills

• Mechanical Engineering
• Biomedical Engineering
• Product Development
• Medical Device Industry
• Highly Regulated Industry
• 3D CAD Modeling
• Engineering Drawings
• SolidWorks
• Technical Writing
• Product Requirements
• Specifications
• Test Protocols
• Test Reports
• Engineering Rationales
• Risk Management
• FMEA
• ISO-14971
• Biocompatibility Evaluations
• Sterilization Evaluations
• ISO 10993-1
• ISO 11737
• Finite Element Analysis
• Statistical Analysis
• Geometric Dimensioning & Tolerancing (GD&T)
• ASME Y14.5
• Change Orders (CO)

Location

• Thousand Oaks, CA

Work Type

• On-site

Experience Level

• Minimum 2 years’ experience in product development

Education Level

• Bachelor’s degree in Mechanical Engineering or Biomedical Engineering

Salary/Compensations

• $98,700 - $120,700

Benefits

• Medical/dental/vision benefits
• 401K match

About the Company

• Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
• Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate.
• Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes.
• An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.
• Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.

Equal Opportunity

• Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
• The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.