Process Engineer II

Harland Medical Systems; Eden Prairie (MN); On-site; USD 85,000 - 110,000; Full time

Job summary

Harland Medical Systems in Eden Prairie, MN seeks a Process Engineer II to support operations in chemical manufacturing. You will design and optimize large-scale processes, create test methods, and develop documentation to meet regulatory standards.

The role requires hands-on troubleshooting, cross-functional collaboration, and a commitment to quality and continuous improvement. The candidate should have a BS in Chemical Engineering with 3+ years of applicable experience, familiarity with ISO

Qualifications

• Bachelor in Chemical Engineering with 3+ years related experience.
• ISO 13485 and/or 21 CFR Part 820 familiarity preferred.
• Strong analytical/problem-solving and ability to summarize/report technical info.
• Statistics knowledge with Minitab preferred.
• Experience with FT-IR, HPLC, and NMR preferred.
• LEAN/Sigma-Six manufacturing experience preferred.
• Self-starter, able to work independently and in a team.
• Detail-oriented and highly organized with multi-project capability.
• Excellent oral and written communication; proficient in MS Office.

Responsibilities

• Design and develop chemical manufacturing processes for large-scale production under FDA-compliant design controls.
• Create and validate new test methods.
• Produce design control documentation for product commercialization.
• Establish technical documentation for internal test plans and protocols.
• Present results to project leaders and team members clearly.
• Write and review manufacturing work instructions and forms.
• Revise documents/processes/methods for improvements.
• Initiate and process document change orders.
• Troubleshoot manufacturing issues.
• Support and/or perform other duties as required.

Skills

Analytical skills

Problem solving

Communication skills

Independent work

Team collaboration

Education

Bachelor of Science in Chemical Engineering

Tools

FT-IR

HPLC

NMR

Minitab

Job description

Reporting To: Business Unit Manager/Local Business Unit Leader

Purpose:

The Process Engineer II provides operations support to meet project goals and timelines for chemical manufacturing with varying technical responsibility. This includes developing, maintaining, optimizing, and improving manufacturing processes and test methods to keep up the needs of the business. All work will be required to stay in compliance with applicable regulations and quality standards in a fast-paced environment.

This position requires a quick learner, who is hands on, and can utilize critical thinking to solve technical problems. Working both independently and collaborating cross-functionally is critical. The selected individual must be able to promote a positive work ethic and demonstrate commitment quality, innovation, and continuous improvement.

Responsibilities:

• Play a key role in designing and developing chemical manufacturing processes for large scale production of various solutions within an FDA compliant design control system.
• Create and validate new test methods.
• Produce the appropriate design control documentation to fulfill the needs for product commercialization.
• Establish technical documentation for internal test plans & protocols for experiment/study execution.
• Communicate and present results to project leaders and other team members clearly and concisely.
• Write and review manufacturing work instructions and applicable forms
• Revise existing documents, processes, and/or methods for corrections and improvements.
• Initiate and process document change orders.
• Troubleshoot issues in manufacturing.
• Support and/or perform other duties as required.

Education, Qualifications and Experience:

• Bachelor of Science degree in Chemical Engineering or related technical degree with 3+ years of experience relevant to this role.
• Previous experience working in a manufacturing environment with a quality management system, preferably in compliance with ISO 13485 and/or 21 CFR Part 820
• Strong analytical/problem-solving skills with demonstrated ability to collect, summarize, and report technical information
• Proficient in application of various statistical techniques and analysis preferred (Minitab a plus)
• Experience analytical equipment such as FT-IR, HPLC, and NMR preferred
• Experience with LEAN/Sigma-Six manufacturing preferred
• Self-starter and motivated individual who works well both independently and with a team
• Detail-oriented, highly organized individual who can handle multiple projects simultaneously
• Excellent oral and written communication skills
• Proficient in the use of Microsoft Office, Word, and Excel.

Working Conditions and Health & Safety:

• Heated and air-conditioned office environment
• ISO Class 7 cleanroom
• Laboratory
• Employee is required to use appropriate PPE including, but not limited to, nitrile or latex gloves, lab coat, hair bonnet, shoe covers, beard cover, safety glasses, hearing protection, face shield, or respiratory mask while working in a lab or manufacturing space

Harland Medical System's commitment to ensure employee health and safety is a priority. Personnel engaged in manufacturing shall obtain training required by ISO 13485, FDA 21 CFR part 820, FDA 21 CFR part 210 & 211, and Harland Medical System's internal procedures, where deemed appropriate per assigned job functions.

Physical Demands:

While performing the duties of this job, the employee is regularly required to sit for prolonged period of time. The employee is frequently required to talk and hear; use hands to handle or feel; and reach with hands and arms above shoulder height and below the waist. Using proper lifting techniques, the employee must be able to lift up to 40 lbs.