Senior Process Engineer

Sanner America (formerly Gilero); Pittsboro (NC); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Annual bonus

Medical plans (BCBS)

Dental & Vision

Life insurance

Parental leave

Disability insurance

401(k) match

LinkedIn Learning

Job summary

Sanner America (formerly Gilero) is seeking experienced Process Engineers to support development and manufacturing of assembly automation for medical devices at our Pittsboro, NC plant. The roles involve designing and implementing manufacturing processes, working with cross-functional teams, and ensuring compliance with ISO 13485 and FDA 21 CFR Part 820.

Candidates should have 3+ years in medical device manufacturing, CAD experience, and strong problem-solving skills; join a collaborative team

Qualifications

• BS in Engineering or equivalent technical degree.
• Minimum 3 years of relevant experience in manufacturing medical devices.
• Knowledge of medical device regulations (FDA/ISO).
• Experience with SolidWorks, Pro/Engineer or other CAD software.
• Experience with Lean/Six Sigma/5S is a plus.

Responsibilities

• Develop and deliver new manufacturing process capabilities including design of experiments (DOE).
• Evaluate device designs for manufacturability (DFM/DFA).
• Establish process flow and line layouts for efficient, scalable manufacturing cells.
• Write and execute protocols to assess process capability (IQ/OQ/PQ).
• Lead project activities with budgets, resources, and timelines.

Skills

Communication

Project coordination

Problem solving

Education

Bachelor's degree in Engineering

Tools

SolidWorks

Pro/Engineer

3D CAD modeling

Excel

Word

Job description

Sanner America (formerly Gilero) is continuing to grow and looking for experienced Process Engineers to support development and manufacturing of exciting assembly automation projects for medical and pharmaceutical delivery devices. Multiple positions and experience levels needed to work at our Pittsboro, NC manufacturing plant.
If you thrive in a fast-paced, collaborative environment and like ensuing high-quality outcomes working with customers, vendors, and internal teams, this is the opportunity for you. As part of the Sanner Group, we share a global culture built on collaboration, transparency, agility, and shared success, united by one purpose: Protecting Health.

Job Summary

The position is responsible for developing new manufacturing systems for emerging technologies to support the production of medical devices under device regulations and standards (ISO 13485 and FDA 21 CFR Part 820). In this role, you will be responsible for designing and implementing manufacturing processes and supporting projects on a scale that can range from developmental pilots to full commercial production.

Responsibilities

• Develop and deliver new manufacturing process capabilities as needed including process selection, characterization and qualification utilizing designed experiment methodology (DOE).
• Evaluate new device designs for manufacturability (DFM/DFA).
• Establish process flow and line layouts to achieve efficient, flexible, and scalable manufacturing cells.
• Utilizes Lean Thinking, Six Sigma and 5S concepts when creating new or improving existing processes.
• Specify and manage external build contractors, install, troubleshoot, and validate automated equipment and processes for complex device assembly and testing.
• Specify new process equipment for manual and fully-automated production lines.
• Write and execute protocols to assess manufacturing process capability (IQ/OQ/PQ).
• Generate CAD models for test or assembly fixtures.
• Establish maintenance requirements for new equipment.
• Evaluate the impact of new processes introductions on critical environments.
• Assess and implement process changes as required by customer request, in response to manufacturing quality issues, or design changes.
• Perform process risk analysis through PFMEA activities to support new or existing processes.
• Maintain Device Master Record (DMR) and ensure documents are complete, accurate, and current including process routers, inspection plans, temporary deviations, and non-conformances.
• Participate in manufacturing investigations/CAPA resolutions to identify improvements to the manufacturing processes.
• Support quality audits of manufacturing processes.
• Drive Continuous Improvement activities within the manufacturing area to meet and exceed operational objectives and goals.
• Develop processes and rates for customer quotations in response to inquiries while working with Tooling, Engineering, Purchasing, and Customer Service to obtain needed information.
• Facilitate design transfer of existing products to and from other manufacturing sites.
• Lead project activities through the management of budgets, resources, timelines, and deliverables.
• Provide engineering expertise in resolving specific technology issues during development and provide support to the production team during ramp and sustaining activities.
• Communicate effectively with customers and vendors in a technical capacity.

Skills/Qualifications

• BS in Engineering or equivalent technical degree.
• Senior and non-senior level positions available. Minimum 3 years relevant experience in manufacturing medical devices.
• Knowledge of medical device regulations (FDA/ISO).
• Experience with SolidWorks, Pro/Engineer and/or other 3D CAD modeling software, preferred.
• Experience with drug filling and handling for combination products, strong plus.
• Ability to program PLC, Arduino, or other motion controllers, strong plus.
• Experience incorporating vision systems into manufacturing equipment for use in in-process inspection and/or motion control, a plus.
• Electro-Mechanical manufacturing assembly experience, a plus. Fully Automated Manufacturing Experience, a plus.
• Excellent communication skills (oral and written).
• Proficient computer skills, including Excel and Word.

Personal Attributes

• Meets Gilero Core Values: Collaboration, Integrity, Innovation, Excellence.
• Comfortable and productive in a fast-paced, entrepreneurial environment.
• A self-starter seeking a career opportunity with potential for internal advancement, seeking responsibility for core activities and providing high quality service to internal and to external clients.
• Commitment to excellence and quality service to external and internal customer.
• Commitment to established policies and procedures, while contributing to continuous improvements.

Eligibility To Work

• Ability to pass a pre-employment background check.
• Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future.
• Gilero does not offer sponsorship for employment authorizations (work visas).
• We are an E-Verify employer and confirm work authorization for all new hires.

Why Sanner America?

Headquartered in Durham, North Carolina, Sanner America is the North American business of the Sanner Group and an end-to-end partner for medical devices, drug delivery systems, and healthcare packaging. Building on the Gilero legacy of more than two decades in design, development, and manufacturing, our teams take products from concept to commercialization. Our culture is built on collaboration, transparency, agility, and shared success, united by the Sanner Group purpose: Protecting Health. US locations include Carlsbad, CA; Chicago, IL; and Durham, Greensboro, and Pittsboro, NC, with additional operations in Mexico.

Sanner offers an annual bonus plan; three BCBS medical plans; dental and vision coverage; company-provided life insurance; paid maternity and parental leave; short- and long-term disability; a 401(k) match beginning the first month after hire with no vesting period; and access to LinkedIn Learning, with over 21,000 courses and certifications for personal and professional development.

Become part of a team motivated by compassion and a shared passion for making a meaningful impact on patients, caretakers, and consumers everywhere!