Senior Process Development Technician

Job Title: Senior Process Development Technician

Department: Advanced Methods

Status: Full Time - Non-Exempt

Reporting To: Global Leader of Engineering and Technology

Position Purpose:

The Senior Process Development Technician supports designing, developing, and optimizing novel manufacturing processes for production transfer, focusing on efficiency and workflow. They work independently and in teams, managing multiple projects, while promoting a positive work ethic and upholding Harland Medical Systems values.

Responsibilities:

The Senior Process Development Technician is responsible for:

• Test new coatings from advanced chemistry; characterize chemistry and provide feedback to Advanced Chemistry team.
• Understand customer criteria to test new chemistries on medical devices and record results.
• Execute coating processes using dispensing methods (slot-die, jet, spray, contact) in fast-paced environment.
• Identify and monitor critical process parameters with SPC tools (Minitab, FMEA).
• Assist with Process Validation (IQ/OQ/PQ), DOE, and machine protocols.
• Perform surface characterization tests (contact angle, etc.) and Gage R&R.
• Follow and maintain pFMEAs, test methods, SOPs, work instructions
• Support equipment setup, qualification, and fixture use
• Understand materials and fixturing
• Train/Mentor operators and technicians
• Conduct technology transfers and provide troubleshooting support
• Communicate results to stakeholders
• Perform other duties as assigned and/or required

Education, Qualifications and Experience:

• Associate’s Degree or technical training in engineering, materials, or related field.
• 2-5 years experience working with coatings, dispensing, fluid handling, and/or surface processes.
• Experience with manufacturing methods, material processing, and process development for various coating methods such as slot-die, contact, jet dispensing, and spray systems
• Experience and ability to perform measurements and/or interpret data from FT-IR, confocal microscopy, contact angle goniometry, tensiometry, XPS, EDS, and AFM
• Previous experience working in a cleanroom environment and/or medical device materials space is a plus.
• Strong analytical skills with the ability to summarize and report technical information.
• Knowledge and experience working with ISO 13485, 10993, and 21CFR Part 820 regulations
• Experience working in cross-functional teams
• Self-starter, detail-oriented, and organized, with strong communication skills
• Proficient in the use of Microsoft Office (Word, Excel, etc.)

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.

Pay: $28.00 - $36.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Retirement plan
• Vision insurance

Education:

• Associate (Preferred)

Experience:

• Process Development Technician: 2 years (Preferred)

Ability to Commute:

• Eden Prairie, MN 55344 (Preferred)

Work Location: In person

Salary : $28 - $36