Senior Process Engineer

Job Description

Job Description

Job Title: Process Engineer- MEDICAL DEVICE EXPERIENCE REQUIRED- RELOCATION OFFERED

Job Description

This Process Engineer role leads the development, sustainment, and validation of manufacturing processes and equipment for medical device products. The position focuses on defining process flows, developing fixtures and tooling, and generating engineering and production documentation for both internal and supplier-based processes. The engineer supports cross-functional projects for existing and new products, recommending specification changes based on manufacturing input, and applies a high degree of creativity and judgment to plan and accomplish complex goals in a regulated environment.

Responsibilities

• Lead the development, sustainment, and validation of manufacturing processes and equipment used in the production of medical device products.
• Determine and document process flows for both internal and supplier-based manufacturing processes.
• Design, develop, and implement fixtures and tooling to support efficient and robust manufacturing operations.
• Generate and maintain engineering and production documentation, including work instructions and process documentation, in accordance with regulatory and internal requirements.
• Work closely with production facilities and vendors to develop, evaluate, document, implement, and improve manufacturing processes throughout the product life cycle.
• Implement and refine process control techniques, related fixtures, and tooling to ensure consistent product quality and process capability.
• Train personnel on new or updated processes and equipment as required.
• Estimate staffing requirements, production times, and relative costs to provide data that supports production planning and decision-making.
• Develop and maintain plans and timelines for project tasks throughout the process development cycle, taking into account resource constraints and project priorities.
• Act as a technical liaison between cross-functional teams and production facilities, including vendors, for both new and existing products and processes.
• Lead process-related risk management activities, including process risk assessments, and support application and design risk management related to products.
• Plan, create, and execute process validations (IQ/OQ/PQ) in accordance with FDA and harmonized standards, including preparation of technical protocols, reports, and feasibility studies.
• Plan, lead, and facilitate production transfers, including production floor layout and facility planning activities such as equipment spacing and utilities.
• Ensure compliance with all standard operating procedures and regulatory requirements related to the development and manufacture of medical devices, including FDA 21 CFR Part 820 and applicable harmonized standards.
• Develop appropriate preventive maintenance plans and coordinate calibration and preventive maintenance activities with Quality and Production departments.
• Collaborate with quality and development engineers to define critical aspects for inspection procedures, gauges, and measurement methods for new and existing products.
• Create and maintain accurate documentation of process specifications, work instructions, tooling drawings, design concepts, shop orders, and related documentation in alignment with R&D and quality assurance requirements.
• Provide engineering support to production facilities and vendors to troubleshoot and resolve technical problems in a timely manner.
• Optimize products, processes, tooling, and equipment to meet customer needs, technical design goals, regulatory and quality requirements, and cost and efficiency targets using Lean and Six Sigma techniques and tools.
• Attend and actively contribute to team meetings associated with assigned projects, providing technical input and progress updates.
• Evaluate new processing technologies and recommend their adoption where they can improve quality, efficiency, or cost-effectiveness.

Essential Skills

• More than 10 years of relevant experience in the medical device and/or pharmaceutical field, with a demonstrated understanding of industry requirements and regulations.
• Proven experience in developing, sustaining, and validating manufacturing processes and equipment for regulated products, preferably medical devices.
• Strong knowledge of FDA 21 CFR Part 820 and harmonized standards relevant to medical device manufacturing.
• Hands-on experience with process mapping, process development, process characterization, qualification/validation, and capability analysis (preferred but strongly beneficial).
• Demonstrated ability to plan, write, and execute process validations (IQ/OQ/PQ), including authoring protocols and reports.
• Experience with process improvements and process layouts in a manufacturing environment.
• Proficiency in Microsoft Office applications, with the ability to create and manage technical documentation, reports, and project plans.

Additional Skills & Qualifications

• Experience in the medical device industry with a focus on process improvement, packaging engineering, and ISO-compliant environments
• Familiarity with medical device process improvement, including packaging process design and validation.
• Experience with Medical Device ISO compliance and related quality system requirements.

Job Type & Location

This is a Contract to Hire position based out of Huntersville, NC.

The pay range for this position is $45.00 - $60.00/hr.

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)

This is a hybrid position in Huntersville,NC.

This position is anticipated to close on Jul 15, 2026.

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 View email address on ziprecruiter.com 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.