Engineer, New Product Introduction in Emeryville, CA at Apex Life Sciences

Date Posted: 3/1/2018

Job Snapshot

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Job Description

Primary Job Function:

Conduct manufacturing process development in collaboration with R&D engineers,

quality engineers, vendors, and consultants.

Design, build and/or acquire equipment, fixtures and tools for device manufacturing,

assembly, inspection, and packaging.

Identify, evaluate and manage material suppliers, manufacturing equipment vendors,

and contract manufacturers.

Translate device designs and product requirements into manufacturing specifications

using design output documents.

Contribute to risk management and FMEAs of manufacturing processes.

Author detailed work instructions and process maps for product manufacturing.

Train technicians on assembly methods, equipment, and procedures.

Troubleshoot and resolve manufacturing issues.

Liaise with contract manufacturers during process development, design transfer, and


Participate in design reviews and identify areas for design improvement, design for

manufacturability (DfM), design for assembly (DfA), and design for test (DfT).

Contribute to the product’s Design History File (DHF) and Device Master Record (DMR).

Identify and follow applicable international standards and regulatory guidance.

Qualifications: BS or MS in Engineering (Biomedical, Industrial, Electrical, or Mechanical preferred), with 3+ years of experience in manufacturing and/or quality.

Skills: The ideal candidate would possess most of the following skills and would be excited to

learn the rest:

You've contributed to the design of products and the development of manufacturing


You're familiar with at least some of the following processes: heat staking, ultrasonic

welding, leak testing, fastener-less assembly, injection molding, PCB assembly, liquid

dispensing, sterilization, and automation.

You can develop 3D models and drawings with SolidWorks or similar CAD tools.

You have experience working in a regulated manufacturing environment

You have experience working with vendors to ensure they meet specifications, lead

times, and budget constraints.

You have experience and interest in hands-on prototyping.

You are familiar with the principles of Six Sigma, Lean Manufacturing, and 5S

You have a strong work ethic and time management skills.

You are able to work both individually and in a team environment.

You have excellent communication and interpersonal skills.