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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