Lead Manufacturing Engineer

4 weeks ago

Bedford, Bedford, United Kingdom Werfen Full time

Overview

Werfen

Werfen is a dynamic, family-owned enterprise based in Barcelona, Spain, recognized globally as a leader in specialized diagnostics across various fields, including 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 operate in 30 countries and extend our reach through distributors in numerous territories. Our Headquarters and Technology Centers are situated in the US and Europe, employing over 7,000 professionals.

Our achievements stem from a dedicated focus on these rapidly advancing diagnostic sectors, a strong commitment to our clients, and an unwavering dedication to innovation and quality. We are passionate about equipping healthcare professionals with the most comprehensive solutions to enhance hospital efficiency and improve patient outcomes.

Job Summary

This position encompasses the dual roles of Senior Engineer and Project Manager. As a Senior Manufacturing Engineer, you will leverage advanced engineering principles to support a diverse array of Manufacturing Engineering tasks, addressing complex challenges related to product design and manufacturing processes, enhancing existing processes, and supporting daily production activities. In the capacity of Project Manager, you will orchestrate and oversee multi-functional product enhancement initiatives, product transfer projects, continuous improvement efforts, and various sub-projects within a broader Global program.

The role demands exceptional leadership capabilities within a highly technical medical instrument environment, necessitating regular collaboration with scientists, hardware and software engineers, technicians, marketing and sales teams, quality assurance, manufacturing personnel, suppliers, administrative staff, and senior management. You will need the confidence to guide skilled technical engineers and scientists in a dynamic, interactive, and energetic setting, directing the project team to achieve anticipated business outcomes.

Responsibilities

Key Accountabilities

  • Technical Leadership: Offer 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 effective risk mitigation strategies.
  • Project Planning and Scheduling: Act as a lead project team member to complete all necessary activities to finalize projects as per established plans. Responsible for project planning, scheduling, and defining the scope of work and specifications.
  • 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 deliverables are completed and documented.
  • Design Control: Author, review, and approve validation protocols, Standard Operating Procedures (SOPs), technical reports, and final reports for new products, processes, and equipment.
  • Regulatory Compliance: Ensure adherence to FDA regulations, Good Manufacturing Practices (GMP), Quality System Requirements (QSR), ISO standards, and other relevant requirements.
  • Continuous Improvement: Identify and implement opportunities for ongoing enhancements.
  • Communication: Manage project communications with both the project team and executive management.
  • Resource Allocation: Ensure the availability of adequate equipment and materials to support project advancement and achieve objectives.
  • Conflict Resolution: Utilize effective listening and negotiation skills to resolve project team conflicts.

Qualifications

Minimum Knowledge & Experience:

  • Bachelor's degree in engineering; advanced degree preferred.
  • Eight years of prior experience in manufacturing engineering is preferred.
  • Experience in a regulated medical device or pharmaceutical environment is essential.
  • Comprehensive knowledge of the complete product lifecycle, including all aspects of product development from conception to manufacturing introduction.
  • Experience in the development and successful launch of at least one medical instrumentation product is desirable.
  • Product development experience, including a minimum of three years in technical leadership, project coordination, or project management.

Skills & Capabilities:

  • Six Sigma Green Belt or Black Belt certification is a plus.
  • Extensive knowledge and experience in process and product manufacturing.
  • Proficient in creating and interpreting engineering drawings, schematics, specifications, tolerancing, and bills of materials (BOMs).
  • In-depth experience with automation development to recommend appropriate design improvements.
  • Expertise in writing and executing validations in a regulated environment.
  • Knowledge of statistical sampling and analysis techniques.
  • Familiarity with FDA regulations, GMP, ISO standards, and OSHA regulations; prior experience with regulatory audits is preferred.
  • Excellent written and verbal communication skills.
  • Strong troubleshooting skills for equipment failures.
  • Proficient in MS Office; familiarity with statistical software and large enterprise resource planning (ERP) systems is preferred.
  • Exceptional 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.

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