• Contract
  • Hire
  • Lowell, MA

Website Agile Workplace Staffing

Agile is looking for a Process Engineer in Lowell MA

The Engineer II, Process Development position is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

What you will be doing

  1. Attends and arranges project meetings to discuss current and future design and development initiatives.
  2. May serve as a primary contact with clients on projects of low to moderate complexity.
  3. Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
  4. Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Have input to project manager for tracking and communicating project status, plans, issues, timelines, action items, and budgets.
  5. Responsible for the following project inputs:
    1. Feasibility builds, documentation, and testing
    2. Equipment selection
    3. Process development and documentation
    4. Device Verification samples and testing
    5. Operator training
    6. Process Failure Mode Effects Analysis
    7. Clinical builds
    8. Process Validation
  6. Involvement in the full design, development, and validation requirements of projects, including:
    1. Product design and specification creation, including mechanical and electrical components, assemblies, and packaging
    2. Materials sourcing and device prototyping
    3. Design verification and validation activities, including data for regulatory submission
    4. Manufacturing transfer and support of existing product lines, as applicable
  7. Reliable, consistent and punctual attendance is an essential function of the job.

Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

What we require from you:

  1. A Bachelors degree in an engineering discipline
  2. Willingness to travel, if required
  3. Must maintain high ethical standards
  4. Must demonstrate good organizational skills
  5. Must be able to read, write and speak fluent English
  6. Experience in an engineering/manufacturing environment with mechanical, tool design, and manufacturing processes preferred
  7. Strong computer skills, including the MS Office suite and MS Project
  8. Must be able to fully interpret technical drawings, blueprints, specifications & illustrations
  9. Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information
  10. Ability to learn and apply new technology
  11. Technical report preparation and formal presentation skills

Working environment

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

We are Committed to Your Success

We offer a competitive package, dynamic work environment, collaborative team, and space to learn, grow and thrive. Qualified applicants will receive consideration regarding race, color, religion, sex, national origin, age, sexual orientation, gender identity, gender expression, veteran status, or disabilities.

If you are a hardworking, driven professional looking for your next team. We are committed to employing a diverse workforce,  let’s start a conversation. Apply today!  


To apply, please visit the following URL:https://cats.agilewps.com/careers/index.php?m=careers&p=applyToJob&ID=1777→