▷ High Salary: Manufacturing Engineer

7 days ago


Shannon, Ireland PBC BioMed Full time

Unit 4D,
Western Business Park,
Shannon,
Co. Clare

Job Description

Job Summary
The Manufacturing Engineer will play a pivotal role in scaling up manufacturing processes from development to commercial production, with a focus on new equipment introduction, process optimization, and validation. This position requires a candidate who can lead the procurement, qualification, and integration of manufacturing equipment while ensuring regulatory compliance and operational efficiency. The ideal candidate will drive technical excellence in manufacturing operations, enabling high-quality production at scale, and collaborate cross functionally to achieve project milestones.

Role and Responsibilities

- Lead the selection, procurement, installation, and commissioning of new manufacturing equipment & utilities to support scale-up and commercialization efforts.
- Collaborate with suppliers to evaluate and qualify new equipment, ensuring compliance with design specifications and regulatory standards.
- Train team members on the operation and maintenance of newly introduced equipment.
- Support manufacturing onsite and at subcontractors/suppliers to ensure that the product quality, regulatory & business requirements are met.
- Track and report progress across project activities by reviewing schedules and due dates, identifying risks and implementing contingency plans. Communicate effectively with all internal & external stakeholders.
- Lead the transition/design transfer of manufacturing processes from R&D to production, ensuring scalability and cost-effectiveness.
- Lead the development and execution of pFMEAs to identify potential failure modes, assess risks, and implement effective controls for manufacturing processes.
- Optimize manufacturing workflows and identify opportunities for efficiency improvements.
- Support timely introduction of any new process upgrades by developing and executing equipment qualification protocols (IQ/OQ/PQ), integrating them into the overall process validation framework.
- Act as a subject matter expert (SME) in manufacturing technologies, troubleshooting complex process issues, and implementing robust solutions.
- Assess and approve process changes ensuring product impact is appropriately considered. Compile any necessary equipment/capital authorization requests supported with appropriate justifications and alternative options.
- Collaborate with key suppliers and their production/manufacturing teams to drive and support process/product improvements/developments.
- Ensure all health, safety and environmental requirements are met.
- Ensure compliance with medical device regulatory requirements, including FDA and ISO 13485 standards.
- Provide guidance and mentorship to junior engineers and technicians, fostering a culture of continuous learning and professional growth.
- Perform other related duties as assigned by their supervisor.

Qualifications and Education Requirements

- Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related field.
- A minimum of 3-5 years of experience in manufacturing engineering, preferably in the medical device or pharmaceutical industries.
- Strong expertise in process validation and equipment qualification in regulated industries.
- Qualifications and education with specialized knowledge of manufacturing with powders, particle processing, and granulation techniques, including safety, quality control, and process optimization, is highly advantageous.
- Knowledge and interpretation of FDA guidelines and ISO 13485 requirements with working knowledge of international standards as applicable.
- Proficient in lean manufacturing, Six Sigma, and other process improvement methodologies.
- Ability to manage multiple projects and prioritize workload effectively to meet project deadlines.
- Excellent communication, interpersonal and presentation skills.
- Strong technical acumen and ability to understand complex technical concepts/issues and develop practical solutions.
- Strong attention to detail and ability to work meticulously to ensure accuracy in testing and documentation.

Note: This description reflects essential functions and does not prescribe nor restrict tasks that may be assigned.

Apply for this Role

Upload your cover letter and resumé here. A maximum of 2 files can be uploaded and each file must be less than 10mb in size.

#J-18808-Ljbffr



  • Shannon, Ireland Martina Quinn Finance Recruitment Full time

    Meet your potential employer? Martina Quinn Finance Recruitment are delighted to be partnering with this high-performing Global leader in sourcing a Revenue Accounting Manager to join their team to ensure compliance with their global revenue recognition standards and provide meaningful & insightful information to the Management team. You will be rewarded...


  • Shannon, Ireland Hobson Prior International Ltd Full time

    Hobson Prior is looking for a Senior Bioprocessing Scientist to join our client's team and drive innovation in cutting-edge biomanufacturing. In this role, you will be an expert in bioprocessing, focusing on the production of gene therapy products and plasmid DNA while ensuring compliance with industry standards. Please note that to be considered for this...

  • Cleaning Supervisor

    3 days ago


    Shannon, Ireland Sodexo Group Full time

    Make a fresh start in a company that cares, as a Cleaning Supervisor with Sodexo in Shannon - V14 AN29! Let your leadership skills sparkle as part of our cleaning services team, in a role where the little details make a big difference. Build a career with big name businesses, in a team that values you for being you. Valued. Recognised. Rewarded. What...


  • Shannon, Ireland Edwards Lifesciences Gruppe Full time

    Senior Director, Manufacturing Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to...

  • IT Project Manager

    2 weeks ago


    Carrick-on-Shannon, Ireland Animal Health Ireland Full time

    Position: IT Project Manager The Organisation Animal Health Ireland is a not-for-profit, public-private partnership, tasked with controlling livestock diseases not subject to international regulation, with the objective of improving the profitability and sustainability of Irish farmers and the agri-food sector. The advice provided by AHI is developed by a...

  • Manufacturing Operator

    20 hours ago


    Shannon, Co. Clare, Ireland Eflexes Full time

    eFlexes are currently recruiting experienced Manufacturing Operatorson behalf of a well-established manufacturing company located in Shannon, Co Clare. Position will be offered on initial 12-month contract, with significant opportunity to extend for the right candidate. To be considered for these roles you will need: 1 to 2 years of experience working in...


  • Shannon, Ireland Extreme Networks Full time

    Extreme Networks Named to Computerworld’s 2023 List of Best Places to Work in IT! Over 50,000 customers globally trust our end-to-end, cloud-driven networking solutions and rely on our top-rated services and support to accelerate their digital transformation efforts and deliver progress like never before. With double-digit growth year over year, no...


  • Shannon, Ireland PBC BioMed Full time

    Unit 4D, Western Business Park, Shannon, Co. Clare Job Description Job Summary We are seeking a skilled and innovative Development Engineer to lead the development and implementation of medical device products in compliance with ISO 13485. This role involves driving the design, documentation, and validation of products throughout their lifecycle, ensuring...

  • Maintenance Manager

    6 days ago


    Shannon, Ireland Hero Recruitment Full time

    Position: Maintenance Manager Location: Shannon, Ireland Company Overview: Our company is a global leader in providing materials for industrial applications. We are at the forefront of technological innovation, serving diverse sectors including aerospace, automotive, and manufacturing. Job Summary: We are seeking a dynamic Maintenance Manager to oversee...


  • Shannon, Ireland Sterling Engineering Limited Full time

    Position: Embedded Design EngineerLocation: Shannon, ClarePermanentThe Role:Our client is a pioneering company dedicated to advancing healthcare technology through innovative solutions. Specializing in the development of cutting-edge medical devices, they are at the forefront of enhancing diagnostics and patient care globally. As an Embedded Design Engineer,...


  • Shannon, Ireland Cregg Recruitment Full time

    Development Engineer (Medical Device) CREGG are seeking a Development Engineer to lead the design, development, and validation of cutting-edge medical device products. Brief Job Description As a Development Engineer, you will manage the full product lifecycle, from concept to commercialisation. You will be responsible for product design, risk assessments,...


  • Carrick on Shannon, Ireland Talent-Curve Full time

    Injection Moulding Process Engineer Location: Co. Leitrim Salary:€45,000 - €55,000 About the Position We are seeking an experienced and detail-oriented Injection Moulding Process Engineer to join a leading manufacturing company in Co. Leitrim. This role offers a fantastic opportunity to work with advanced injection moulding technologies, driving...


  • Carrick-on-Shannon, Ireland TTM Healthcare Solutions Full time

    TTM Healthcare Solutions (TTM) have partnered with a leading organisation to hire Support Workers based in Manorhamilton, Co. Leitrim for agency work. This is a Residential service for adults with Intellectual Disabilities. There is a mixture of days (8am - 8pm) & nights (8pm - 8pm) shifts available. As an agency worker with TTM, you will enjoy greater...

  • Production Supervisor

    2 weeks ago


    Shannon, Ireland Aerogen Ltd Full time

    About Aerogen: Headquartered in the vibrant city of Galway, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards and eight-time winner of the Zenith award for Respiratory Care Excellence in North America, collectively our employees make a difference to...


  • Shannon, Ireland FRS Recruitment Full time

    Are you an experienced QA professional seeking a pivotal role in a dynamic and innovative environment? Join a leading team specialising in Gene Therapy medicinal products, where your expertise in Quality Assurance, Validation, and Qualification will contribute directly to groundbreaking advancements in healthcare. As a QA Validation Specialist, you will...


  • Shannon, Ireland Edwards Lifesciences Full time

    Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us...


  • Shannon, Ireland Edwards Lifesciences Gruppe Full time

    QA Supervisor - Day Shift Apply locations: Ireland-Shannon Time type: Full time Posted on: Posted 7 Days Ago Job requisition id: Req-36801 Make a meaningful difference to patients around the world. At Edwards Lifesciences, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. Your attention to detail and...

  • IT Systems Engineer

    3 weeks ago


    Shannon, Ireland Sterling Engineering Limited Full time

    IT SpecialistJob descriptionWe are thrilled to offer an exciting opportunity for an experienced IT Specialist to join my Clients growing Team! This is a dynamic, hands-on role that involves a high level of activity and responsibility.The position has been created to support the continued growth of the business and the increasing demands on our IT...


  • Shannon, Ireland Aerogen Ltd Full time

    About Aerogen: Headquartered in the vibrant city of Galway, Ireland, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards and eight-time winner of the Zenith award for Respiratory Care Excellence in North America, collectively our employees make a difference to...


  • Carrick-on-Shannon, Ireland CPL Full time

    Moulding Process Engineer My client, a global design and manufacturing organisation is looking to recruit a Moulding Process Engineer. The primary function of the Moulding Process Engineer is to assume responsibility for the control and management of all process driven systems within the Injection Moulding department and direct daily activities in...