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Bedford, Bedford, United Kingdom Werfen Full timeJob SummaryThis role requires a combination of technical expertise and leadership skills to support the development and implementation of manufacturing processes and products. As a Senior Manufacturing Engineer, you will apply advanced knowledge of engineering principles and analyses to solve complex problems and improve manufacturing efficiency.Key...
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Senior Manufacturing Engineer
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Bedford, Bedford, United Kingdom Werfen Full timeJob SummaryThis role requires a combination of technical leadership and project management skills to support a complex range of manufacturing engineering activities. As a Senior Manufacturing Engineer, one will apply advanced knowledge of engineering principles and analyses to solve multifaceted issues related to product design and manufacturing processes....
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Senior Manufacturing Engineer
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Bedford, Bedford, United Kingdom Werfen Full timeJob SummaryThis role requires a unique blend of technical expertise and leadership skills to drive manufacturing engineering activities and project management initiatives. As a Senior Manufacturing Engineer, you will apply advanced knowledge of engineering principles to solve complex problems related to product design and manufacturing processes. As a...
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Bedford, Bedford, United Kingdom Werfen Full timeJob SummaryThis role requires a unique blend of technical expertise and leadership skills to drive manufacturing engineering activities and project management initiatives. As a Senior Manufacturing Engineer, you will apply advanced knowledge of engineering principles to solve complex problems related to product design and manufacturing processes. As a...
Lead Manufacturing Engineer
2 months ago
Overview
Werfen
Werfen is a dynamic, family-owned enterprise established in Barcelona, Spain, recognized globally for its expertise in specialized diagnostics, particularly in Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplantation. Our Original Equipment Manufacturing (OEM) division focuses on the research, development, and production of tailored assays and biomaterials. We have a direct presence in 30 countries and operate in numerous others through our distributor network. Our Headquarters and Technology Centers are strategically located in the US and Europe, employing over 7,000 professionals.
Our achievements stem from a dedicated focus on these rapidly advancing diagnostic fields, unwavering commitment to our clients, and a strong emphasis on innovation and quality. We are devoted to equipping healthcare professionals with the most effective and comprehensive solutions to enhance hospital efficiency and improve patient outcomes.
Job Summary
This position blends the responsibilities of a Senior Engineer and Project Manager. As a Senior Manufacturing Engineer, the individual will leverage advanced engineering principles to support a wide array of Manufacturing Engineering activities. This includes addressing complex challenges related to product design and manufacturing processes, enhancing existing processes, and supporting daily production operations. In the capacity of Project Manager, the individual will orchestrate and oversee multi-functional product enhancement initiatives, product transfer projects, continuous improvement efforts, and various sub-projects within a larger Global program.
The role demands robust leadership capabilities in a highly technical medical instrument setting, necessitating regular collaboration with scientists, hardware engineers, software engineers, technicians, marketing/sales teams, quality assurance, manufacturing, suppliers, administrative staff, and senior management. The individual must possess the confidence to guide proficient technical engineers and scientists in a dynamic and engaging work environment, steering the project team towards achieving the anticipated business outcomes.
Responsibilities
Key Accountabilities
Technical Leadership: Deliver technical and team leadership to cross-functional project teams, ensuring compliance with design requirements and applicable standards. Problem Solving Leadership: Coordinate technical resources to identify root causes of project issues and develop comprehensive plans for resolution, testing, and implementation. Risk Management: Ensure that both technical and management risks are identified and addressed within the project plan, developing risk mitigation strategies as necessary. Project Planning and Scheduling: Act as a lead project team member to finalize all activities required to complete projects as per established plans. Responsible for project planning, scheduling, and defining the scope of work and specifications. Utilize milestone methods and critical path scheduling for resource planning and task development to meet business objectives. Process Control Development: Establish and implement process controls for product transfers to manufacturing or new manufacturing sites. Project Execution and Control: Conduct regular project team status meetings and reviews, overseeing validation project teams and ensuring all deliverables are completed and documented. Design Control: Author, review, and approve validations (installation qualification IQ/operational qualification OQ/performance qualification PQ protocols, Standard Operating Procedures (SOP), technical reports, and final reports) for new products, processes, and equipment. Compliance Assurance: Ensure adherence to FDA regulations, Good Manufacturing Practices (GMP), Quality System Requirements (QSR), ISO standards, and other relevant requirements across all projects and processes. Continuous Improvement: Identify and implement opportunities for ongoing improvement. Communication: Manage project communications with both the project team and executive management. Resource Allocation: Ensure the availability of adequate equipment and material resources to support project advancement and achieve objectives. Conflict Resolution: Utilize effective listening and negotiation skills to resolve conflicts within the project team.Qualifications
Minimum Knowledge & Experience:
Bachelor's degree in engineering; advanced degree preferred. A minimum of eight years of experience in manufacturing engineering is preferred. Previous experience in a regulated medical device or pharmaceutical environment is essential. Comprehensive knowledge of the complete product lifecycle, including all facets of product development from conception to manufacturing introduction, is required. Experience in the development and launch of at least one successful medical instrumentation product is desirable. Proven product development experience, including a minimum of three years in technical leadership, project coordination, or project management roles, is required.Skills & Capabilities:
Six Sigma Green Belt or Black Belt certification is a plus. Extensive knowledge and experience in process and product manufacturing are required. Proficiency in creating and interpreting engineering drawings, schematics, specifications, tolerancing, and bills of materials (BOMs). In-depth experience with automation development to recommend appropriate design enhancements. Expertise in writing and executing validations in a regulated environment. Knowledge of statistical sampling and analysis methodologies. Familiarity with FDA regulations, Good Manufacturing Practices (GMP), ISO Standards, and Occupational Safety and Health Administration (OSHA) regulations; experience with regulatory audits is preferred. Exceptional written and verbal communication skills. Strong troubleshooting skills for equipment failures are essential. Proficient in MS Office; familiarity with statistical software and large enterprise resource planning (ERP) systems is preferred. Excellent organizational and time management skills, with a keen attention to detail.Travel Requirements:
Approximately 20% travel may be required, including international mobility.
Werfen is an Equal Opportunity employer, committed to fostering a diverse workplace. We strictly prohibit unlawful discrimination, harassment, or retaliation based on any protected characteristic as defined by applicable state or federal law.
