Senior Process Development Technician

Provides advanced technical support in the development, validation, and optimization of manufacturing processes for medical devices, ensuring compliance with regulatory and industry standards. Works closely with engineering and quality teams to implement process improvements that drive product quality, efficiency, and scalability.

Responsibilities

Support the development and validation of manufacturing processes for medical devices in compliance with industry standards and regulatory requirements; Collaborate with engineering and quality teams to design and implement process improvements that enhance product quality and operational efficiency; Troubleshoot process deviations and defects, implementing corrective actions to maintain consistent product quality; Support builds for feasibility studies, design verification, and process validation activities; Train operators on new and revised manufacturing processes; Support Process Development Engineers in evaluation and qualification of new equipment and fixtures; Manage inventory of raw materials and assemblies that are used for development builds; Complete relevant tasks to fulfill major milestones, identifying key parameters and all other requirements for products

Requirements

2-year degree or related vocational/apprenticeship or 4-6 years equivalent industry experience; Experience working within a controlled environment; Solid understanding of technical concepts and principles; Effective communication skills to collaborate with cross-functional teams; Understanding of Good Manufacturing Practices (GMP) and regulatory standards such as FDA and ISO 13485; Experience with a variety of manufacturing processes, which may include automated equipment and manual processes that may require work utilizing a microscope; Good written and verbal communication and notation skills; Proficient in Good Documentation Practices (GDP); Ability to work independently; Familiarity with Microsoft Office Products (Word, Excel, PowerPoint, etc.); Ability to take verbal instructions and translate them into goals and objectives; Pro-active; high-performance and results orientation; Ability to consistently work with ethical integrity; Personifies Coloplast Mission, Values and Vision as well as Coloplast Leadership Principals

Nice to have

Medical Device manufacturing background preferred

Benefits

Comprehensive medical, dental, and vision insurance plans; Company sponsored wellness programs and mental health resources; Paid leave of absence for qualifying events; Competitive 401(k) plan with company match that vests immediately; Financial planning services; Corporate discount programs; Generous paid time off; Flexible work hours and flexible work arrangement options; Professional development opportunities through training programs, mentorship, and tuition reimbursement; Recognition programs, bonuses, awards, and special events; Team-building activities, volunteer opportunities, and company-sponsored events; Supportive work environment