Purpose of the Role :
The Process Development Specialist will be responsible for developing manufacturing processes for new products, ensuring efficient production of high-quality components, and programming coordinate measuring machines (CMM) with both tactile and optical systems. This role is integral to design transfer, process optimization, and continuous improvement initiatives within the advanced operations department.
Key Responsibilities :
Develop and implement manufacturing processes for new product introduction (NPI) in collaboration with design and process engineers.
Program and optimize coordinate measuring machines (CMM) for both tactile and optical measurement techniques.
Ensure process and product quality align with operational and material specifications.
Support project and process engineers in defining test process flows , conducting Design of Experiments (DOE) , and executing DFM / DFI tasks.
Develop and execute test strategies , select and develop test equipment , and create CMM programs while ensuring proper documentation.
Set up test systems, conduct measurement program qualification , and document results thoroughly.
Perform initial sample, first-piece, and in-process testing to validate production processes.
Lead and support qualification and validation activities related to measuring systems.
Train production employees on measurement techniques and process adherence .
Ensure strict compliance with GMP standards, safety procedures, and quality regulations .
Conduct maintenance planning and execution for measuring equipment.
Execute additional tasks as assigned by the supervisor.
Required Skills & Competencies :
Proven expertise in CMM programming (tactile & optical) with experience in MCOSMOS from Mitutoyo being an advantage.
Strong background in metrology and measurement system analysis (MSA).
Proficiency in GD&T (Geometric Dimensioning & Tolerancing) and ability to interpret complex engineering drawings and D models.
Experience in process validation and quality assurance within a regulated environment (medical technology experience preferred).
Hands-on experience with SPC software (, Q-DAS) for statistical analysis and process control.
Knowledge of industry standards and trends in metrology and manufacturing processes.
Proficiency in Microsoft Office Suite (Word, Excel, Outlook) .
Strong analytical and problem-solving abilities with a logical and strategic mindset.
Excellent communication skills and ability to work in cross-functional teams.
Fluency in German is required; English is an advantage.
Education & Experience :
Formal training in coordinate measuring technology (AUKOM / EUKOM Level - preferred).
Prior experience in medical device manufacturing or other regulated industries is an advantage.
Development Specialist • Skawina