Senior Process Development Technician

Coloplast; Minneapolis (MN); On-site; USD 30,000 - 40,000; Full time

Benefits offered by this job

Comprehensive medical, dental, and vision insurance

401(k) plan with company match

Paid time off and flexible work hours

Professional development opportunities

Recognition programs and community events

Job summary

Coloplast in Minneapolis is seeking a Technical Support Specialist for manufacturing processes in medical devices. This role entails supporting the validation and optimization of manufacturing processes and ensures compliance with regulatory standards.

Ideal candidates will have a manufacturing background, especially in medical devices. The position offers competitive hourly rates starting at $30.55 and opportunities for professional development and flexible working arrangements.

Qualifications

• Experience in medical device manufacturing preferred.
• Experience working within a controlled environment.
• Solid understanding of technical concepts and principles.

Responsibilities

• Support the development and validation of manufacturing processes.
• Collaborate with teams to design and implement process improvements.
• Troubleshoot process deviations and defects.

Skills

Manufacturing processes knowledge

Effective communication skills

Understanding of GMP and regulatory standards

Proficiency in Microsoft Office Products

Education

2-year degree or related vocational/apprenticeship

4-6 years equivalent industry experience

Job description

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.

Major Areas of Accountability

• 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.
• Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the MedTech Code of Conduct, and company policies.
• Other duties as assigned.

Basic Qualifications

• 2-year degree or related vocational/apprenticeship or 4-6 years equivalent industry experience.
• Medical Device manufacturing background preferred.
• 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.

Required Knowledge, Skills and Abilities

• 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.

Benefits

• Health and Wellness: Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus, access to company‑sponsored wellness programs and mental health resources, paid leave of absence for qualifying events.
• Financial Security: A competitive 401(k) plan with company match that vests immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.
• Work‑Life Balance: Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.
• Professional Development: Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
• Recognition and Rewards: Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
• Community and Culture: A supportive work environment where everyone feels valued and has a sense of belonging. Participate in team‑building activities, volunteer opportunities, and company‑sponsored events. Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.
• Competitive Compensation: The starting hourly rate for this position is $30.55/hr. Hired candidates may be eligible to receive additional compensation for applicable experience and may also be eligible for bonuses and/or incentives. Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location.

Equal Employment Opportunity

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

Coloplast Group - Holtedam 1 - Humlebaek - DK 3050 - Denmark