rev1 engineering and filmecc- medical device design and manufacturing logo

Join Our Team

About Us

Rev.1 Engineering has locations in Temecula and Murrieta, California.

We are committed to serving our clients and providing the best possible experience. Our team thrives on innovation, customer service, and a continuous drive for quality and improvement. We offer competitive compensation, comprehensive benefits, and a collaborative work environment, everyone here is empowered to excel in a dynamic, innovative organization.

Learn More

Careers

Check back soon! There are no positions currently available.

Principal D&I Program Manager

The Principal D&I Program Manager manages projects of increased complexity and size and is the
primary contact between the client and engineering.

Duties and responsibilities
The Principal D&I Program Manager must be able to perform the essential functions of this job with or without reasonable accommodations. Reasonable accommodations may be made for individuals with a disability so long as the accommodations do not provide an undue hardship to the company.

  • Help Recruit key talent and ensure resource levels are commensurate to workload.
  • Manage resourcing, workflow, timelines and budgets
  • Maintain and build client relationships; primary contact point for client interactions, meet with clients on a regular basis
  • Develop and manage client budgets
  • Expert in, and able to own and drive to completion, the Product Development Process (PDP)
  • Expert in project planning, quoting and selling proposals for new projects
  • Be an owner of internal programs, procedures and business strategies
  • Create an environment that fosters innovation, continuous improvement, develop new processes and technology to improve efficiency and preserve corporate culture
  • Act as an organizational leader; lead by example
  • May supervise lower level program managers

Qualifications
The minimum qualifications that are necessary for someone to fulfill the roles and responsibilities of the Principal D&I Program Manager role are as follows:

  • Expert in Critical Chain Project Management (CCPM) or equivalent project management software
  • Expert in managing complex cross functional product development teams
  • Expert in the medical device product development process (PDP)
  • Expert in operating in an ISO 13485 quality system
  • Familiar with FDA/CE regulatory requirements
  • Highly oriented to customer service and quality improvement

Desired Qualifications

  • MBA

Education / Experience

  • Bachelor of Science in Engineering or related field
  • 10-15 years of experience
  • MBA (Desired)

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. The general working conditions for this role will typically include a regular, day shift, though occasional work during an alternate shift may be necessary. Work may occur at both sites, REV.1 Headquarters at Enterprise Circle, and REV.1 Manufacturing at Date Street. Employee may also encounter challenging client interactions during project assignments that require a calm, and professional demeanor from this role.

Physical requirements
Physical requirements may include:

  • Sitting for long periods of time
  • Lifting up to 50 lbs.
  • Ability to travel, as required

Disclaimer
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Employment is at will.

Sr. Medical Device Design Engineer

Responsibilities

  • Support the design and development of medical devices from prototype through production
  • Work as part of a team to meet project deliverables
  • Able to take direction and work independently with minimal supervision
  • Draft test protocols and reports with collaboration with higher level engineers
  • Able to execute a test protocol, oversee technicians, collect and reduce data
  • Document work
  • Prepare technical slides to be used in update meetings
  • Present a positive and professional demeanor

Required Qualifications

  • Good interpersonal skills
  • Able to work in a team environment
  • Highly motivated, mature and responsible
  • Some proficiency in SolidWorks or other relevant CAD software
  • Familiar with MS Office products

Education / Experience

  • Bachelor of Science in Engineering or related field
  • 0-2 years of relevant work experience

Job Type: Full-time

Pay: From $95,000.00 per year

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Flexible spending account
  • Health insurance
  • Health savings account
  • Life insurance
  • Paid time off
  • Vision insurance

Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday
  • Overtime

Supplemental pay types:

  • Bonus opportunities

Engineering Project Manager

1. Job purpose

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

2. Duties and responsibilities

The employee must be able to perform the essential responsibilities of this job with or without reasonable accommodations. Reasonable accommodations may be made for individuals with a disability so long as the accommodations do not provide an undue hardship to the company.

· 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.

· Demonstrating advanced knowledge of project and program management principals.

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

· Mentoring other project managers.

· 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

Required:

· 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

Preferred:

· 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

6. Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Employment is at-will.

Job Type: Full-time

Pay: $135,000.00 – $155,000.00 per year

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Employee discount
  • Flexible spending account
  • Health insurance
  • Health savings account
  • Life insurance
  • Paid time off
  • Vision insurance

Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday
  • Overtime

Supplemental pay types:

  • Bonus opportunities

Ability to commute/relocate:

  • Temecula, CA 92590: Reliably commute or willing to relocate with an employer-provided relocation package (Required)

Senior Quality Engineer

1. Job purpose

The Senior Quality Engineer role supports the organization through engineering activities, quality assurance activities, and occasional quality control activities. The Senior Quality Engineer role is a shared resource and is responsible for providing quality engineering support to both Development and Innovation (D&I) and manufacturing. The Senior Quality Engineer role will also support the management of the QMS, and will have authority to perform quality functions and decision-making as appropriate to the position level. This role must be able to work independently with minimal supervision, manage and prioritize their work load, and able to act as a technical quality lead.

2. Duties and responsibilities

The employee must be able to perform the essential responsibilities of this job with or without reasonable accommodations. Reasonable accommodations may be made for individuals with a disability so long as the accommodations do not provide an undue hardship to the company.

2.1.General Responsibilities

2.1.1. Support QMS development and on-going maintenance through monitoring and identification of needs for procedural improvements and supporting QMS projects related to ISO13485 and transition of QMS into Greenlight Guru.

2.1.2. Oversee and supervise quality support tasks performed by technicians and inspectors for proper execution.

2.1.3. Assist with organization training for ISO standards and QMS requirements through development and presentation of training materials.

2.1.4. Mentor and develop engineers and technicians to deepen their understanding of industry and QMS requirements, and best practices for developing and commercializing safe and effective medical devices.

2.1.5. Manage and support quality assurance activities as requested.

2.2.Manufacturing Responsibilities

2.2.1. Provide technical quality engineering support for commercialization activities such as daily line support, change order approvals, protocol & report writing, etc.

2.2.2. Perform Quality Control activities as required, for Incoming Quality Inspection and manufacturing line, and provide training to QC inspectors.

2.2.3. Utilize statistical tools to support process control and process improvements; implement new inspection and data collection methodologies when required.

2.2.4. Perform critical review of design changes and oversight to implementation through crossfunctional teamwork.

2.2.5. Analyze and resolve complex manufacturing and compliance issues (e.g., nonconformances, CAPAs, audit observations.) in a timely manner.

2.3.Development and Innovation Responsibilities

2.3.1. Support design control deliverables and regulatory submission deliverables as required for assigned projects through cross-functional teamwork, protocol and report writing, test method validations, etc.

2.3.2. Provide technical quality engineering support for design transfer deliverables.

2.3.3. Provide quality engineering support to Pilot production activities to ensure processes are characterized and scalable.

2.3.4. Partner with D&I engineers to develop and validate critical processes.

2.3.5. Partner with D&I engineers & Manufacturing Engineers to develop training plans for assemblers/QCs to support knowledge transfer for new product introductions into manufacturing.

3. Qualifications

The minimum qualifications that are necessary for someone to be a Senior Quality Engineer are as follows:

● Bachelor of Science in Engineering or related field

● 5-10 years of experience within the medical device industry, with at least two years as a Quality Engineering professional/or other similar Quality role

● Strong Understanding of Medical Device Product Development Process (PDP).

● Strong Understanding of how to operate in an ISO13485 quality system.

● Strong Understanding of FDA/CE regulatory requirements

● Knowledge of basic statistics

● Able to work in a collaborative team environment

● Able to act as technical quality lead

● Able to communicate and interface with clients in a professional manner

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. The general working conditions for this role will typically include a regular, day shift, though occasional work during an alternate shift may be necessary. Work conditions also require ability to enter and exit from the CER, and may include extended periods of time in the CER. Work will occur at both sites, REV.1 Headquarters at Enterprise Circle, and REV.1 Manufacturing at Date Street. Employee may also encounter challenging client interactions during project assignments that require a calm, and professional demeanor from this role.

5. Physical requirements

Physical requirements may include:

  • Prolonged periods of time working on a computer
  • Sitting for long periods of time
  • Lifting up to 30 lbs.
  • Ability to commute between REV.1 sites as required for routine, daily tasks.
  • Ability to travel, as required

6. Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Employment is at will.

Job Type: Full-time

Pay: $95,000.00 – $130,000.00 per year

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Health insurance
  • Life insurance
  • Paid time off
  • Vision insurance

Schedule:

  • 8 hour shift
  • Monday to Friday

Work Location: In person

Submit your application.

Rev.1 Employee Traits

Experimental

We have a trial-and-error mindset and view failures as learning opportunities.

Collaborative

We find clever ways to solve challenges either solo or as a team.

Empathetic

We emphasize understanding and listening in the workplace.

Ownership-Minded

We are self directed and feel empowered to make decisions or ask for help when we need it.

Resourceful

We find ways to creatively meet objectives even when facing limitations.

Problem-Solver

We find clever ways to solve challenges either solo or as a team.

Creative

We aren't afraid to think outside the box when trying to solve problems.

Hands-On

We activley seek solutions and execute on them ourselves.

Learner

We are constantly learning and exploring new ways to innovate.