Senior Process Engineer

Advantage Technical; Bedford (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Senior Process Engineer to join their R&D Hardware Engineering team. This role is pivotal in leading cross-functional projects and ensuring the successful transfer of innovative medical diagnostic products from concept to high-volume manufacturing. The ideal candidate will have a strong mechanical engineering background, excellent communication skills, and a proactive approach to problem-solving. This position offers a unique opportunity to make a significant impact in the medical diagnostics field while working in a fast-paced, highly regulated environment.

Qualifications

• 6-8 years of experience in a regulated environment, preferably medical device.
• Experience in New Product Introduction (NPI) and manufacturing transfer.

Responsibilities

• Lead cross-functional projects to meet technical milestones.
• Ensure compliance with FDA policies and internal quality standards.

Skills

Mechanical Engineering

Project Leadership

Communication Skills

Statistical Analysis

FDA Regulations

Problem-Solving

Education

Bachelor's Degree in Mechanical Engineering

Job description

Position Summary:

We are seeking a driven and technically adept Senior Process Engineer with a strong mechanical engineering foundation to join our R&D Hardware Engineering team. This individual will lead cross-functional projects, supporting the development and transfer of innovative medical diagnostic products from concept through to high-volume manufacturing. The ideal candidate is an excellent communicator, a proactive collaborator, and someone who thrives in a fast-paced, highly regulated environment.

As a key contributor in our product development lifecycle, the Process Engineer will apply standard engineering techniques, procedures, and judgment to solve complex problems, design scalable processes, and ensure compliance with FDA and industry standards. This role demands a clear vision, strong leadership, and the ability to drive progress across functional boundaries.

Key Responsibilities:

Primary Functions:

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  Lead or contribute to technical projects with cross-functional teams, ensuring project milestones are met on schedule.

  
  


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  Plan, prioritize, and execute engineering tasks aligned with organizational goals.

  
  


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  Author and maintain clear, detailed documentation supporting design controls, product development, and manufacturing transfer.

  
  


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  Apply Design for Manufacturing (DFM) principles to new and existing product designs.

  
  


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  Support the transfer of products from R&D to high-volume manufacturing environments, ensuring scalability and quality.

  
  


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  Develop test methods, specifications, and fixtures for mechanical components and assemblies.

  
  


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  Identify product defects and outliers, documenting findings and their impacts with clarity.

  
  


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  Communicate technical concepts and results through presentations, written reports, and collaborative discussions.

  
  


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  Ensure compliance with FDA policies and internal quality standards.

  
  

Secondary Functions:

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  Provide technical guidance or mentorship to junior engineers as needed.

  
  


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  Propose process or procedural improvements within the function.

  
  


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  Assist in schedule planning and resource allocation for engineering tasks.

  
  

Required Skills & Capabilities:

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  Strong mechanical engineering foundation, with hands-on experience in design, test fixtures, and manufacturing processes.

  
  


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  Demonstrated leadership and project ownership skills, with the ability to influence cross-functional teams.

  
  


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  Excellent written and verbal communication skills.

  
  


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  Analytical mindset with experience in statistical analysis and data interpretation.

  
  


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  Familiarity with FDA regulations, design control, and documentation practices.

  
  


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  Ability to work independently and prioritize multiple projects effectively.

  
  


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  Proactive, solutions-oriented attitude with a passion for problem-solving and continuous improvement.

  
  

Minimum Qualifications:

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  Bachelor's degree in Mechanical Engineering or related discipline.

  
  


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  6-8 years of experience in a regulated environment, preferably medical device or diagnostics.

  
  


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  Proven stability in prior roles (minimum of 4-5 years with a previous employer).

  
  


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  Experience in New Product Introduction (NPI), including product development and transfer to manufacturing.

  
  

Preferred Experience:

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  Experience designing and developing mechanical assemblies and test fixtures.

  
  


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  Prior involvement in scaling products to high-volume manufacturing.

  
  


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  Strong understanding of DFM principles and supplier engagement.

  
  

Internal Collaboration:

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  Regular interaction with cross-functional teams including R&D, Quality, Regulatory, Manufacturing, and Supply Chain.

  
  

This is a highly visible role offering an exciting opportunity for an engaged, motivated engineer looking to grow their career while making a real impact in the medical diagnostics space

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About Advantage Technical

With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.

Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact your local branch. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.