Engineer

Job Title: Engineer Job Description This contract role focuses on process development within the medical device industry, supporting catheter delivery systems through process validation, equipment design, and technical documentation. The engineer will apply core engineering principles to develop, validate, and improve manufacturing processes, working closely with cross-functional teams to ensure safe, efficient, and compliant production. Responsibilities

- Author and execute process validations, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Product Performance Qualification (PPQ), Test Method Validation (TMV), and Inspection Method Validation (IMV).
- Lead and support process development activities, including equipment specification, acquisition, installation, and implementation for catheter delivery system manufacturing.
- Apply engineering principles, theories, concepts, practices, and techniques to analyze and solve process-related problems in a structured and data-driven manner.
- Plan and complete Design of Experiments (DOE) to characterize processes, optimize parameters, and drive continuous improvement initiatives.
- Perform testing and data analysis for process characterization and validation, and present findings and recommendations to equipment and project teams.
- Evaluate current equipment and processes for suitability, and develop detailed plans and proposals for process and equipment improvements.
- Create and revise manufacturing documents, including specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and other technical documents to support compliant and efficient operations.
- Write and maintain technical reports, manufacturing procedures (MPs), and SOP documentation to ensure clear, accurate, and traceable process information.
- Collaborate with other engineers and technicians to develop solutions and improvements in materials, equipment, and processes as needed.
- Participate in cross-functional teams to support continual improvement, safety, and regulatory compliance across R&D, Quality Engineering, Manufacturing Engineering, and Operations.
- Provide training and process expertise to production and engineering teams in areas such as process development, tooling development, and validation activities.
- Interact effectively with internal and external stakeholders, including cross-functional partners and customers, to support project goals and resolve technical issues.
- Support assembly operations, UV curing, and mechanical assembly processes specific to catheter delivery systems.
- Contribute to the development and refinement of new methods or materials that enhance product quality, process efficiency, and overall manufacturing performance.

Essential Skills

- 13 years of engineering experience, preferably in process development or related roles.
- Experience in the medical device industry, including internships or early-career roles.
- Bachelors degree in Mechanical Engineering or Biomedical Engineering, or a closely related engineering discipline.
- Ability to author and execute process validations, including IQ, OQ, PQ, PPQ, TMV, and IMV.
- Demonstrated understanding of core engineering principles, theories, concepts, practices, and techniques.
- Hands-on experience with equipment design, specification, and implementation in a manufacturing or laboratory setting.
- Strong technical writing skills for manufacturing procedures, technical reports, SOPs, validation protocols, and risk assessments.
- Experience with Design of Experiments (DOE) and process characterization methodologies.
- Proficiency in data analysis and the ability to interpret test results and validation data to drive decisions.
- Ability to work cross-functionally with R&D, Quality Engineering, Manufacturing Engineering, Operations, and other stakeholders.
- Experience with assembly operations, UV curing, or mechanical assembly processes, particularly in a medical device context.
- Strong attention to detail and a commitment to safety, compliance, and continuous improvement.

Additional Skills & Qualifications

- Masters degree in an engineering discipline is welcome but not required.
- Electrical or Software Engineering backgrounds may be considered if the candidate demonstrates strong fit with process development and validation requirements.
- CAD software experience is highly desirable for equipment and tooling design and development.
- Experience with statistical analysis tools; Minitab experience is a plus, and academic exposure to statistical methods is acceptable.
- Exposure to quality management and documentation systems such as TrackWise, electronic lab notebooks, or MasterControl is beneficial but not required.
- Profile in R&D or product development is welcomed, especially where it relates to medical devices or catheter delivery systems.
- Ability to present technical data clearly to equipment teams and cross-functional groups.
- Strong interpersonal and communication skills for effective collaboration and training.
- Demonstrated ability to suggest and support new methods or materials that improve quality and efficiency.

Work Environment This is an onsite engineering contractor role based in a medical device manufacturing and development environment, focused on catheter delivery systems. The engineer works on-site five days per week, with a typical schedule of approximately 8:00 AM to 5:00 PM and some flexibility in hours, provided there is consistent attendance. The environment includes hands-on work with process development equipment, assembly operations, UV curing systems, and mechanical assembly processes, as well as office-based tasks for data analysis and technical documentation. Collaboration with R&D, Quality Engineering, Manufacturing Engineering, and Operations is integral to the role, fostering a culture of continuous improvement, safety, and compliance. Candidates willing to relocate to Minnesota are eligible, and virtual interviews are available for non-local applicants.
Job Type & Location
This is a Contract position based out of Bedford, MA.
Pay and Benefits
The pay range for this position is $37.00 - $40.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:

Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)
Job Type & Location
This is a Contract position based out of Bedford, MA.
Application Deadline
This position is anticipated to close on Nov 17, 2026.
Workplace Type
This is a fully onsite position in Bedford,MA. About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without
regard to race, sex, age, color, religion, national origin, veteran status, disability,
sexual orientation, gender identity, genetic information or any characteristic protected
by law.

If you would like to request a reasonable accommodation, such as the modification or
adjustment of the job application process or interviewing process due to a disability,
please email [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the
city and county of San Francisco, we will consider for employment qualified applicants
with arrest and conviction records.

Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a
condition of employment or continued employment. An employer who violates this law
shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):
We may use Artificial Intelligence (AI) to support parts of our hiring process,
including sourcing, screening, and evaluating candidates. AI helps assess applications
and qualifications, but final decisions are made by our hiring team. By applying, you
acknowledge and agree that your application may be reviewed using AI tools.