Manager, Engineering Test & Analysis Group, Combination Product Development

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An engineering professional who applies project management knowledge, engineering knowledge, and ingenuity to plan, execute, and deliver testing needs with robust documentation associated with pipeline assets by managing a small team and combination product (medical device) test laboratory at LC. The job will ensure coordination of activities between CPD groups in LC (Lake County, USA) and LU (Ludwigshafen, Germany) to leverage and optimize site capabilities.

Major Responsibilities:

  • Responsible for leading a small team of engineers, technicians, and contractors (between 2-5), ensuring optimal resource utilization, and forecasting resource needs based on planned activities.

  • Manage multiple programs (devices to deliver pipeline assets) using strong project management skills to plan and schedule activities over the course of 9-12 months.

  • Responsible for providing laboratory support, as well as building capabilities within the department. Lab support includes managing medical device test preparation and execution activities, as well as supporting internal and external audits.

  • Responsible for ensuring the lab equipment maintenance and calibration schedule is sustained.

  • Manage the Design Verification process for multiple devices/combination products such as auto-injectors, on-body delivery systems, and infusion pumps for both clinical studies as well as commercial approval and launch to ensure the device meets design requirements and comply to global regulations (FDA, MDR, etc.). The process includes creation of verification plans, protocols, and reports.

  • Manage the team and activities associated with defining, developing, and validating test methods using lab equipment to perform engineering confidence testing and design verification testing. Test method validation ensures the procedure or method is suitable for its intended use to consistently produce reliable analytical results.

  • Drives and/or participates in department continuous improvement initiatives focused on maximizing process efficiencies, and enhanced collaboration within and outside of the department.

  • Engage and collaborate with clinical, project development, audit, regulatory, and commercial teams, as well as, external engineering partners to ensure alignment across the organization throughout device development activities and deliverables.

  • Develop, foster relationship, and partners with the CPD Engineering Test & Analysis department in Ludwigshafen, Germany to ensure optimized use of resources and lab capabilities, as well as coordination of activities of both facilities.

  • The Manager will ensure adherence to policy/procedures related to applicable standards, specifications, EHS, quality, and GMP manufacturing.

Requirements:

  • Qualification:
  • A Bachelors Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 8+ years of significant engineering and/or operational experience. A post-graduate education/degree is desired, and may contribute towards the desired years of experience. Has demonstrated competency within a discipline.

  • Has a career history marked by a consistent series of technical contributions and accomplishments. Significant contribution to product or process development or improvement through creative application of technical effort will equally be recognized.

  • Possesses a strong technical knowledge and application of concepts, practices, and procedures. Works on problems of complex scope where analysis of situations or data involves multiple competing factors. Exercises judgment and advises management as to the appropriate actions.

  • Proven project management skills is required. Managing projects and programs in a matrixed organization is preferred. Progressively increased responsibility and performance as a supervisor or manager is a plus.

  • Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators.

  • Listens to and understands others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentations.

  • Works well with other engineers in a collaborative, fast-paced goal-driven environment.

  • Possesses interpersonal skills to negotiate and reconcile differences.

  • Has a technical background in health care, medical devices, pharmaceutical, biologics, or similar industries (preferred).

  • Fluency in German language is strongly preferred.

Key Stakeholders: (optional) List key internal and/or external interfaces

  • CMC, R&D, R&D QA, EH&S, Operations, Commercial, Clinical, Regulatory.

Additional Information

  • Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
  • Travel: Yes, 5 % of the Time
  • Job Type: Experienced
  • Schedule: Full-time
  • Job Level Code: M

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