Job Description

Job Description

Job Description

Overview

The Prototype Technician will provide prototyping, fabricating, and modeling capabilities for the development of medical devices. This is a hands-on position that utilizes a range of equipment to produce prototypes including their components, tooling, and fixtures. The design and development will span concept and early development through to post-market activities. This additionally includes providing input into the overall medical device design and development process as a member of the Production & Engineering team.

This position involves tasks such as utilizing rapid prototyping tools and equipment (e.g. 3D additive printers, CNC machining), as well lathe, milling, and other traditional machining equipment. The employee should be capable of performing hands-on prototyping; utilizing CAD software to create, modify, and analyze designs; drafting and interpreting of engineering drawing for both production and prototyping for products, tooling, and fixtures; and participation in the design control processes. Additional experience with low volume molds, design for manufacture, and proof-of-concept assemblies is of added benefit. This job is well suited for someone who can take ownership and initiative to create prototypes and models based on team inputs and guidance with minimal supervision. This is an on-site, full-time position.

Reports to:

VP Production & Engineering

Duties and Responsibilities:

The Prototype Technician responsibilities typically involve:

• Fabrication of prototype components, assemblies, tooling, fixtures, and fittings to support product development, assembly, manufacturing, and packaging processes.
• Development and review of prototype designs by both CAD modelling and hands-on prototyping.
• Support drafting of engineering drawings and CAD for both production and prototyping.
• Work collaboratively in development of innovative production techniques and manufacturing processes for all stages of device development.
• Perform maintenance activities on fabrication/workshop machinery and equipment.
• Perform all documented work in compliance with ISO 13485:2016 and FDAs Quality System Regulations.

Skills and Experience:

The Prototype Technician should be able to utilize and develop existing skills to find innovative ways to fabricate and machine product development prototypes and resolve any issues that arise. The following abilities will aid the Prototype Technician in completion of these tasks:

• Highly proficient with CAD (Solidworks) and CAM (Fusion360) for creating, modifying, and analysis of, prototypes and components.
• Highly proficient in a hands-on workshop environment for prototyping and tooling development, including a range of rapid prototyping tools and equipment (e.g. 3D additive printers, CNC machining), as well lathe, milling, and other traditional machining equipment.
• Experienced with metrology equipment (e.g. calipers, micrometer) for inspections and design purposes.
• Familiar with standard industrial manufacturing techniques.
• Creativity to aid in finding innovative ways to create and fabricate prototypes, tooling, process, and manufacturing techniques.
• Problem-solving abilities to find resolutions to any issue as they arise during the development of prototypes and/or processes.
• Strong math and skills to make accurate measurements, calculations, and designs as required.
• Self-motivated with strong time management skills to ensure completion of tasks within strict timelines.
• Highly organized.
• Excellent communication skills.
• Ability to work well in a cross-functional collaborative team.
• Familiar with Microsoft Office Suite.
• Must be able to lift 50 lbs.

Preferred Education and Training:

• 3+ years' experience in CAD/CAM and workshop environment.
• 3+ years in machining operations for fabrication (i.e., metalworking lathe, vertical mill, 3-axis and 4-axis CNC machining).
• 3+ years of experience with 3D printing and additive manufacturing processes.

Preferred but not required:

• Bachelor's Degree in Industrial Design, Engineering or related field.
• Proficiency in Photoshop, Illustrator, and InDesign.
• Experience in prepress production and color matching.
• Experience assembling or designing soft goods/textiles.
• Experience rendering or animating mechanical CAD assemblies using Solidworks, Fusion360, Rhino, Grasshopper, or Unreal Engine.
• Authorization to work in the United States indefinitely without restriction or sponsorship.

Critical Innovations is an Affirmative Action/Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veterans' status, or any other characteristic protected by law.

To conform to U.S. Government Department of Defense regulations, you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State.

Benefits:

• 401(k) Safe Harbor Plan
• Healthcare Insurance: Medical, Dental and Vision
• Other Insurance: Life Insurance and Long-Term Disability (LTD) Insurance
• Time Off: Paid Time Off (PTO), Paid Sick Leave, Paid Holidays, and Paid Bereavement Leave
• Tuition Reimbursement Program
• Performance Bonus
• Flexible Schedule
• Lunches, Snacks, Events

Schedule:
Monday to Friday

Salary
$60,000 - $90,000 per year

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