1+ months

Project Lead

Rev1 Engineering
Temecula, California 92590

Project Lead – REV1 Engineering

Are you looking for a new opportunity and sick of cold weather? Check out this opportunity in sunny Temecula, CA at REV1 Engineering. REV1 designs state of the art medical devices and is located in the beautiful Southern California wine country which is 60 miles NE of San Diego. If you have medical device PM experience we’d like to talk with you!

1. Job purpose

The purpose of the Project Lead is to lead development of Class I/II/III medical devices in a dynamic, customer-focused organization. The Project Lead will work with customers to develop design input specifications and design, build, and test devices to those specifications.

2. Duties and responsibilities

· Function as both an individual contributor and lead small cross-functional teams comprised of engineering, operations, and quality members to develop detailed engineering specifications, perform device design and development, and support verification, validation, and regulatory submissions of these devices, then transfer to production

· Work within the constraints of budget, schedule, and scope while managing risk and ensuring adherence to established processes and regulations.

· Interacting with customers, suppliers, and internal resources.

· Demonstrate advanced knowledge of project and program management principals.

· Using project management tools to manage medical device development projects.

· Defining and managing scope, time, and resources of large scale, complex projects or programs.

· Facilitating identification of project or program risks, developing and assigning responsibility for mitigation actions, and managing the mitigation plan.

· Refining project management methodologies for quality and project or program risk management.

· Providing engineering services in a phased development approach to develop & launch medical devices.


3. Qualifications


· BS in Engineering or related field (Mechanical, Biomedical, Chemical)

· Minimum of 7+ years of related work experience in the medical device field

· Experience working through all aspects of medical device design & development including design verification and validation, process validation, and technology transfer

· Ability to lead a team toward operational objectives with aptitude to contribute to strategic goal setting for department/business unit

· Ability to function with little or no supervision

· Experience with process validation (IQ, OQ, PQ), test method definition, root cause analysis, gage R&R, and measurement systems analysis (MSA)

· Ability to perform statistical analysis using k-factors, Ppk, and DOEs along with root cause analysis

· Highly oriented to customer service and quality improvement


· Experience developing designs and testing via a phase-gate analysis (Concept, Feasibility, Verification) and using a risk-based approach (dFMEA)

· Experience operating in an ISO13485 Quality System

· Familiar with FDA/CE regulatory requirements

· Subject matter expertise in a directly applicable sub-field (e.g. medical device development, mechanical assembly, catheter systems, injection molding, extrusions, electro-mechanical, etc.)

· Proficiency in design and 3-D modeling (i.e. SolidWorks)

· Design for manufacturability and assembly (DFMA)

· Creation of risk assessments & failure mode element analysis

· Six Sigma Green/Black Belt

· Proficiency with MS Project and ProChain

· Experience and understanding of the design of catheters and/or injection-molded components

· The ability to perform statistical analysis to ensure quality output of components & assemblies

4. Working conditions

To successfully perform the essential functions of this job, the physical demands and work environment described here are representative of those necessary for the employee to successfully perform their role with or without reasonable accommodations. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job so long as it does not cause an undue hardship to the company.

5. Physical requirements

Physical requirements may include:

● Prolonged periods sitting at a desk and working on a computer.

● Must be able to lift up to 15 pounds at times.

● Must be able to navigate various departments of the organization’s physical premises.

● Ability to travel as, required


Salary Details

Competitive compensation package including PAID benefits.  Relocation will also be offered.



  • Engineering
Posted: 2022-12-23 Expires: 2023-02-06

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Project Lead

Rev1 Engineering
Temecula, California 92590

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