Product Development Engineer

envista; Thousand Oaks (CA); On-site; USD 99,000 - 121,000; Full time

Job summary

Envista is seeking a Product Development Engineer to drive the main elements of New Product Development for surgical implants, prosthetics, and instruments. You will work within the Design Engineering team on concept development to production transfer, including verification, validation, and usability assessments.

This on-site role in Thousand Oaks, CA requires a BS in Mechanical or Biomedical Engineering and 2+ years in regulated medical device development.

Qualifications

• Bachelor's degree in Mechanical or Biomedical Engineering.
• Minimum 2 years in product development, preferably medical devices.
• Proficient in 3D CAD modeling and engineering drawings (SolidWorks or similar).
• Strong technical writing and documentation skills.
• Experience with FMEA and risk management.

Responsibilities

• Generate development documentation compliant with ISO 13485 and FDA 21CFR Part 820.30.
• Conduct risk management (FMEA) and document results per ISO-14971.
• Perform biocompatibility and sterilization evaluations per ISO 10993-1 and ISO 11737.
• Perform Finite Element Analysis as needed.
• Perform statistical analysis for test results and sample size rationale.
• Review drawings and GD&T per ASME Y14.5; develop protocols/reports and COs.
• Coordinate with vendors and project teams for timely action items.
• Assist in new product introductions and design transfers.

Skills

3D CAD modeling

Engineering drawings

Technical writing

FMEA

Statistical analysis

Education

Bachelor's degree in Mechanical Engineering or Biomedical Engineering

Tools

SolidWorks

Job description

Job Description:

The Product Development Engineer is engaged in executing the main elements of New Product Development to introduce surgical implants, prosthetics, and instruments to market. In this role, you will participate in the following: Concept Development, Design & Development, Design Verification & Validation, and Design Transfer to production. You will serve as a core team member of the Design Engineering team, while partnering with cross-functional experts on projects. You will participate in the planning and execution of Design Verification & Validation activities and participate in activities including product & packaging performance evaluation, Biocompatibility assessments, Usability Studies and Sterilization Validation assessment.

This role would be on-site 5 days per week in Thousand Oaks, CA

Job Requirements:

ESSENTIAL DUTIES:

• 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.

MINIMUM REQUIREMENTS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE:

• Bachelor's degree in Mechanical Engineering or Biomedical Engineering
• Minimum 2 years' experience in product development; medical device or another highly regulated industry is highly preferred
• 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.

Target Market Salary Range:

Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.

$98,700 - $120,700

Operating Company:

Implant Direct

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.

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