Join the Team

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

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

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.