Director II, Engineering

Meso Scale Diagnostics, Llc. • Gaithersburg, MD

150d • $174,100 - $272,050

About The Position

The Director II, Engineering Plastics Design is responsible for contributing to the department strategy and leading major engineering projects to support Engineering R D product development. The Director II, Engineering will lead and manage engineers and technicians participating in product development and product enhancement activities. In conducting this work, the Director II, Engineering will work closely with other internal groups as well as external groups such as key vendors. Additionally, the Director II, Engineering Plastics Design will be a subject matter expert and individual contributor to consumable design activities to enable high-volume, low cost manufacturing of consumable products.

Requirements

• Bachelor's degree in Mechanical or Plastics Design Engineering or a closely related field required.
• Twelve (12) years of relevant experience or a combined ten years of relevant experience and postgraduate education leading to a degree required.
• Five years of direct or matrixed supervisory experience required.
• Expert-level knowledge of design for injection molding required.
• Demonstrated portfolio of products designed for scale manufacturing, greater than 1M units per year.
• Strong leadership skills with demonstrated knowledge and understanding of staff management practices and processes.
• Strong business acumen, negotiation and mediation skills, as well as a demonstrated attention to detail and a focus on achieving quality outcomes.
• 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 translating biological assay functions to consumable products required.
• Solid knowledge of product development processes, especially under Design Control.
• Excellent analytical and problem-solving skills.
• Excellent oral, written and interpersonal skills.
• Proficiency in SolidWorks and MS Office suite.

Nice To Haves

• Post graduate degree preferred.
• Expert-level knowledge of compliance requirements of an ISO cGMP environment preferred.
• Strong knowledge of analytical techniques, experimental design, and statistical analysis preferred.

Responsibilities

• Subject matter expert in the design of plastic components, selection of materials, assembly methods, and packaging to support high-volume, injection molded consumables.
• Lead cross-functional teams in the design and development of MSD consumable products, including leading design and design review activities.
• Develop project proposal documents including project schedules and budgets.
• Develop product documentation such as product requirements, technical designs, and specification documents.
• Manage the design and development of MSD consumable components against product requirements, specifications, schedule, and budget.
• Manage the system integration and engineering testing of MSD consumable products.
• Manage the formal verification and validation of MSD consumable plastic designs.
• Manage the launch and post-launch sustaining engineering of MSD instrumentation products.
• Work with Commercial and Industrial Design teams to define, translate, and meet User experience requirements for MSD kit components.
• 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 managers and other 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 and/or approve 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 ISO9001 and ISO13485.
• Lead collaboration efforts with service team to gain information on field performance and reliability of kit consumables to ensure that continuous product improvement is in place.

Benefits

• Medical, dental, and vision coverage, along with prescription benefits.
• 401(k) plan with company matching.
• Flexible spending accounts.
• Company-paid short- and long-term disability insurance.
• Group life and accidental death and dismemberment insurance.
• Paid vacation, paid sick leave, paid holidays, and paid parental leave.
• Employee assistance program.
• Fitness club membership contribution.
• Pet insurance.
• Identity theft protection.
• Home and auto insurance discounts.
• Optional supplemental life insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree