Manufacturing Process Lead

4 days ago


Stockholm, Stockholm, Sweden Nordberg Medical AB Full time

Nordberg Medical AB is seeking a skilled Manufacturing Process Lead to drive the development, optimization, and validation of manufacturing processes for our medical devices. This role involves scaling up projects, improving efficiency and product quality, and collaborating with cross-functional teams to implement advanced manufacturing techniques.

This position requires strong analytical thinking, attention to detail, effective communication skills, and collaboration abilities.

Key Responsibilities
  • Lead the design, development, and optimization of manufacturing processes for new and existing medical device products.
  • Collaborate with manufacturing teams and alliance partners on production development, technology transfer, and efficient, scalable, and compliant production processes.
  • Develop, document, and maintain process workflows, control plans, and standard operating procedures (SOPs).
Process Validation and Qualification
  • Conduct process validation activities, including Installation, Operational, and Performance Qualification (IQ/OQ/PQ) for new and modified manufacturing processes.
  • Evaluate and ensure validation protocols align with regulatory standards (e.g., ISO 13485, GMP, and FDA 21 CFR Part 820) and are executed effectively to meet quality requirements.
  • Analyze and document validation results, addressing any deviations or non-conformances.
Continuous Improvement and Optimization
  • Identify, lead, and execute continuous improvement projects to enhance process efficiency, reduce waste, and improve product quality.
  • Lead root cause analyses for any process failures or deviations, and in collaboration with the Quality Department implement corrective and preventive actions (CAPAs) as necessary.
Regulatory Compliance and Documentation
  • Evaluate and ensure all production processes comply with medical device regulations and standards, including FDA, ISO, and other applicable guidelines.
  • Prepare, review, and maintain comprehensive documentation related to process design, validation, and improvement activities.
Qualifications
  • Around 5-8 years of experience in manufacturing engineering or process engineering, preferably within the medical device, pharmaceutical, or regulated healthcare industry.
  • Bachelor's degree in engineering (e.g., Mechanical, Biomedical, Industrial, or Manufacturing Engineering) or related field. A master's degree is a plus.


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    Job SummaryWe are seeking a Senior Production Process Engineer to lead and support the development, optimization, and validation of manufacturing processes for implantable Class III medical devices at Nordberg Medical.Responsibilities:Design, develop, and optimize manufacturing processes for new and existing implantable medical device products.Collaborate...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    PharmaRelations ApS seeks a highly skilled Senior Production Process Engineer to lead and support the development, optimization, and validation of manufacturing processes for our implantable Class III medical devices.Key ResponsibilitiesLead the design, development, and optimization of manufacturing processes for new and existing implantable medical device...


  • Stockholm, Stockholm, Sweden ALTEN Sweden Full time

    About UsALTEN is one of Europe's largest technology and IT consulting companies, employing over 57,000 people across nearly 30 countries. We have approximately 1,300 employees spread across 9 offices in Sweden.Job DescriptionWe are looking for a talented individual to join our team as a manufacturing process optimization specialist. In this role, you will...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    Job OverviewThis position will be at the forefront of our company's growth ambition, overseeing planning, coordination, and execution of all aspects of assigned projects in a complex supply chain/external manufacturing environment.About the RoleWe are seeking an experienced project management professional to lead product launches and lifecycle initiatives...


  • Stockholm, Stockholm, Sweden Nordberg Medical AB Full time

    We are seeking a highly experienced Senior Manufacturing Engineer to join our team at Nordberg Medical AB. The successful candidate will be responsible for leading and supporting the development, optimization, and validation of manufacturing processes for our medical devices.This role involves scaling up projects, improving efficiency and product quality,...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    PharmaRelations ApS is seeking a highly skilled Senior Production Process Engineer to join our team. In this role, you will lead and support the development, optimization, and validation of manufacturing processes for our implantable Class III medical devices.Key ResponsibilitiesDesign, develop, and optimize manufacturing processes for new and existing...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    Senior Production Process EngineerWe are committed to delivering exceptional medical device manufacturing solutions, and we need talented professionals like you to help us achieve this goal.In this critical role, you will lead the development, optimization, and validation of manufacturing processes for implantable Class III medical devices, working closely...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    Job DescriptionNordberg Medical seeks a Senior Production Process Engineer to drive manufacturing process development, optimization, and validation for implantable Class III medical devices.Key Responsibilities:Lead the design, development, and optimization of manufacturing processes for new and existing implantable medical device products.Collaborate with...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    As a Senior Production Process Engineer at PharmaRelations ApS, you will be responsible for leading and supporting the development, optimization, and validation of manufacturing processes for our implantable Class III medical devices.Key ResponsibilitiesDevelop and implement efficient, scalable, and compliant production processes.Collaborate with...


  • Stockholm, Stockholm, Sweden Nordberg Medical AB Full time

    Nordberg Medical AB seeks a highly skilled Engineering Process Optimization Specialist to lead and support the development, optimization, and validation of manufacturing processes for our medical devices. This role involves scaling up projects, improving efficiency and product quality, and collaborating with cross-functional teams to implement advanced...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    Celonis TN Sweden is looking for a highly skilled Business Process Optimization Lead to join its Nordics Value Engineering function based in Stockholm. As a key member of the team, you will be responsible for leading the development and execution of comprehensive business process optimization strategies that drive value for customers.About the JobYou will...


  • Stockholm, Stockholm, Sweden Nordberg Medical Full time

    Process Engineering ManagerWe are looking for an experienced Process Engineering Manager to lead and support the development, optimization, and validation of manufacturing processes for implantable Class III medical devices at Nordberg Medical. This role requires a strong understanding of GMP, ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    Strategic Manufacturing Transformation ExpertThe Strategic Manufacturing Transformation Expert plays a crucial role in leading the design of large-scale manufacturing transformations. This position requires a strong background in business process analysis and enterprise solution architecture.Responsibilities:Lead key discussions and drive architecture...


  • Stockholm, Stockholm, Sweden Nordberg Medical AB Full time

    Nordberg Medical AB is looking for a seasoned Production Process Development Manager to oversee the development, optimization, and validation of manufacturing processes for our medical devices. This role involves scaling up projects, improving efficiency and product quality, and collaborating with cross-functional teams to implement advanced manufacturing...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    Large Scale Manufacturing Transformation ConsultantThe Large Scale Manufacturing Transformation Consultant is responsible for leading the design of large-scale manufacturing transformations. A strong background in business process analysis and enterprise solution architecture is required for this role.Responsibilities:Lead key discussions and drive...


  • Stockholm, Stockholm, Sweden g2 Recruitment Full time

    A leading recruitment agency is seeking a mid-senior level Tooling Engineer to join their team.Job Description:Develop and design tooling solutions for composite and structural components in a high-performance environment.Responsibilities include:Oversee tooling fabrication, testing, and validation to ensure compliance with quality standards.Work closely...


  • Stockholm, Stockholm, Sweden Manta Full time

    Company OverviewManta is a leading manufacturer of innovative products, and we are seeking an experienced Manufacturing Manager to join our team. As a key member of our leadership group, you will play a critical role in overseeing product delivery and ensuring that our operations meet the highest standards of quality and efficiency.


  • Stockholm, Stockholm, Sweden DELTACLASS TECHNOLOGY SOLUTIONS LIMITED Full time

    About the RoleWe are seeking a Manufacturing IT Consultant to join our team at DELTACLASS TECHNOLOGY SOLUTIONS LIMITED. As a key member of our team, you will be responsible for designing and implementing SAP architectures that support the manufacturing domain, ensuring alignment with business objectives and technology standards.Main Responsibilities:Develop...


  • Stockholm, Stockholm, Sweden HCLTech Full time

    Job DescriptionWe are hiring an SAP Enterprise Architect for HCLTech's Stockholm location. As a key member of our team, you will be responsible for developing and maintaining the overall SAP architecture strategy for the manufacturing domain.Responsibilities- Develop and implement SAP solutions tailored to manufacturing processes, ensuring integration with...


  • Stockholm, Stockholm, Sweden Infosys Technologies Sweden AB Full time

    We are looking for an experienced Senior Leader to head our Client Services Group in Sweden, covering the entire Nordics region. This role requires a strong background in serving clients in Sweden and the Nordics within the IT Services area.The successful candidate will be responsible for:Providing timely client introductions to internal teams.Navigating...