Senior Process Engineer – Manufacturing Scale-Up (Medical Devices)

Novus Scientific is looking for a Senior Process Engineer to lead the scale-up of manufacturing for our Class III implantable medical devices. This is a hands-on, high-responsibility role aimed at expanding production capacity, with potential to design and implement a completely new manufacturing site. Experience with medical textiles and/or polymer chemistry are strong advantages.

Company: Novus Scientific

About the Role

Your initial focus will be to understand the full production process—step by step—and identify opportunities for improved efficiency and throughput. Based on this, you’ll develop a detailed plan for scaling up manufacturing, which may include reengineering workflows, sourcing equipment, building new infrastructure, and preparing for future growth.

You will then lead the execution of this plan: specifying and installing equipment, validating processes, training personnel, and ensuring compliance with all relevant regulations.

In order to fully understand the current products and processes there will be a great level of support from our organization in order to onboard you in a good way! 

Key Responsibilities 

Scale-Up Leadership

• Analyze current production processes to identify capacity limits, inefficiencies, and improvement opportunities.
• Develop and execute a roadmap to scale production significantly.
• Drive planning and implementation of potential new manufacturing facilities or major expansions.

Process Engineering & Validation

• Design and implement scalable, efficient, and compliant production processes for Class III implantable medical devices.
• Lead all validation activities (IQ/OQ/PQ) per GMP, ISO 13485, and FDA 21 CFR Part 820.
• Ensure documentation, traceability, and regulatory compliance across all activities.

Implementation & Team Enablement

• Source, install, and commission new production equipment.
• Train production personnel on new processes, equipment, and standards.
• Collaborate closely with R&D, Quality, Regulatory, and Operations to ensure alignment and smooth execution.

Qualifications

Required

• 5–8 years of experience in process engineering for Class III medical devices, ideally including scale-up projects.
• Experience from manufacturing meaning developing workflows, workstation and equipment improvements.
• Degree in Mechanical, Biomedical, Manufacturing, or Industrial Engineering.
• Proven experience leading validation activities (IQ/OQ/PQ).
• Familiar with cleanroom environments.
• Fluent in English; able and willing to travel regularly to Uppsala, Sweden.

Preferred

• Knowledge of polymer chemistry and material behavior under sterilization and processing conditions.

Personal Attributes

• Independent and self-driven – thrives on autonomy and ownership.
• Proactive and fast-moving – comfortable in a dynamic, entrepreneurial environment.
• Strategic and hands-on – able to plan long-term while executing day-to-day.
• Collaborative and communicative – effective across disciplines and cultures.

What we offer

• Participation in projects that impact society and assist patients.
• Competitive salary and a comprehensive pension plan.
• Flexible working hours, remote work options, and generous vacation policies.
• Continuous learning opportunities including training, workshops, certifications, and support for attending conferences.
• Collaborative, inclusive, and respectful environment where every voice is valued.
• Health and wellness benefits.
  
  
• 🌴 30 days of vacation each year
• 💰 ITP1 occupational pension
• 💌 Occupational group life insurance, work injury insurance & business travel insurance
• 🎾 Yearly wellness allowance 

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