Director , Engineering

POSITION SUMMARY

The Director I, Engineering is responsible for leading major engineering projects under the supervision of the VP of Engineering. The Director I, Engineering will lead and manage engineers and technicians participating in product development and product enhancement activities. In conducting this work, the Director I, Engineering will work closely with other internal groups as well as external groups such as key vendors.

• Lead cross‑functional teams in the design and development of MSD instrumentation products, including:

  • Develop project proposal documents including project schedules and budgets
  • Develop product documentation such as product requirements and specification documents
  • Manage the design and development of MSD instrumentation products against product requirements, specifications, schedule, and budget
  • Manage the system integration and engineering testing of MSD instrumentation products
  • Manage the formal verification and validation of MSD instrumentation products
  • Manage the launch and post‑launch sustaining engineering of MSD instrumentation products

• Work with cross‑departmental teams to support the design, development integration, production and after‑sales support of MSD instrumentation, associated test kits, consumables and reagents.

• Manage, coach and develop team members while motivating them to meet and exceed goals. Promote a culture of high performance and continuous improvement that values learning and a commitment to quality.

• Author project communications such as project status updates, key technical decisions, and test results.

• Manage engineering work to ensure compliance with MSD's quality systems including ISO 9001 and ISO 13485.

• Lead collaboration efforts with service team to gain information on instrument field performance and reliability to ensure that continuous product improvement is in place.

• Specific duties may vary depending upon departmental requirements.

• Bachelor's degree in Systems, Mechanical, or Electrical Engineering or a closely related field required
• Post graduate degree preferred
• Ten years of relevant experience or a combined ten years of relevant experience and postgraduate education leading to a degree required
• Four years of direct or matrixed supervisory experience required

• Strong knowledge of medical or scientific instrument and/or consumables design required
• Strong knowledge of compliance requirements of an ISO cGMP environment required
• Solid knowledge of analytical techniques, experimental design and statistical analysis preferred
• Strong leadership skills with demonstrated knowledge and understanding of staff management practices and processes and the ability to establish accountabilities and expectations and manage performance to achieve results
• Strong business acumen, negotiation and mediation skills, as well as a demonstrated attention to detail and a focus on achieving quality outcomes. Ability to build/foster relationships.
• Demonstrated ability to meet deadlines, manage processes through to completion and coordinate a high level of activity under a variety of conditions and constraints
• Knowledge of integrating complex, automated life sciences or clinical systems required
• Solid knowledge of product development processes, especially under Design Control
• Excellent analytical and problem‑solving skills
• Logical problem solving and demonstrated ability to organize and move project tasks forward in an orderly and structured fashion
• Excellent oral, written and interpersonal skills
• Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of project status
• A wide variety of creativity and latitude is expected including the ability to multi‑task in an environment with changing priorities
• Demonstrated ability to develop, integrate and validate systems, in a GMP, ISO or other regulated production environment
• Proficiency in MS Office suite

While performing the duties of this job, the individual is frequently required to sit or stand for long periods. The individual is occasionally required to walk; use hands and fingers to…