Director, Engineering Product Development (Instrumentation and Disposables)

Location
Gaithersburg, MD
Posted
Oct 28, 2021
Hotbed
BioCapital
Required Education
Masters Degree/MBA
Position Type
Full time

MaxCyte is a leading provider of cell-engineering platform technologies to advance innovative cell-based research, development, and commercialization of next- generation cell therapies. The company's existing customer base ranges from large biopharmaceutical companies — including 20 of the top 25 pharmaceutical companies based on 2020 global revenue — to hundreds of biotechnology companies and academic translational research centers. MaxCyte has granted 14 strategic platform licenses to commercial cell therapy developers that allow for more than 75 clinical programs. Founded in 1998, MaxCyte is headquartered in Gaithersburg, Maryland, US.

Job Summary:

The Director of Engineering Product Development, researches, plans, designs, develops, and validates life science instrumentation, disposables, assembly processes and equipment. The Director of Engineering Product Development generates and implements ideas/concepts for new products and product upgrades and is involved in every aspect of instrumentation and disposable development and manufacture to meet the needs of engineering and manufacturing departments, business customers, scientists, and clinical partners. The incumbent manages multiple engineering projects and resources ensuring projects are completed on time and with high quality results.

Job Responsibilities:

• Responsible for all aspects of product development including: product concepts, product definition, technical specification, documentation, product design- process, DFM with high volume automation objective, product manufacturing integration, and qualification/validation

• Build, lead and manage the engineering team, including outsourced engineering services

• Establish annual new product development engineering goals, objectives, and project/program budgets

• Create product development documentation to support the design control stage gate process and meet GMP requirements oct 2021

• Work in tandem with internal and external business partners across all teams to help deliver company goals

• Develop measurable product requirements based on user needs

• Create project schedules including resource needs

• Lead the product design and assembly process enhancements of new and existing products

• Review design information and specifications to determine critical to quality parameters of design and components

• Design for manufacturing (DFM). Develop products considering maximum variation needed to mass produce using manufacturing automation

• Develop assembly processes for disposables that are flexible and can be scaled to meet high annual volumes and high mix disposable product lines

• Support lifecycle of engineering change controls

• Support sustaining engineering activities

• Ensure new product technical transfer activities are comprehensive and successful

• Work with automation vendors to determine assembly methods and techniques in the early stage of product design (Design for Automated Manufacturing)

• Support, as needed, technical investigations pertaining to MaxCyte products

• Establishes and maintains engineering standards and procedures

• Complies and adheres to all Company health, safety and environmental policies

• Other duties as assigned

Job Requirements:

• Master's degree in engineering, mechanical, electrical, biomedical sciences, bio- engineering, or related field with 12+ years of relevant experience. MBA a plus.

• Proven managerial track record including, managing multiple project teams and effectively hiring and motivating staff and teams resulting in successfully commercialization of products

• Demonstrated experience building strategic and executable engineering growth plans to support business goals and initiatives

• Experience designing Disposable products for high-volume production (Automation)

• Working knowledge of FDA requirements

• Plastic injection molding part design and mold design experience oct 2021

• Experience with biocompatible material selection for fluid path single use sterile disposables

• Track record of developing new technologies and solving difficult problems

• Excellent interpersonal and communication skills

• Hands on experience with design control and change control

• Project Management Professional (PMP) or similar certification a plus

Leadership Competencies:

• Action Oriented – Ability to take on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm. Readily takes action on challenges, without unnecessary planning. Identifies and seizes new opportunities. Displays a can-do attitude in good and bad times. Steps up to handle tough issues.

• Collaborates – Builds partnerships and works collaboratively with others to meet shared objectives. Represents own interests while being fair to others and their areas. Partners with others to get work done. Credits others for their contributions and accomplishments. Gains trust and support of others.

• Decision Quality – Makes good and timely decisions that keep the organization moving forward. Makes sound decisions, even in the absence of complete information. Relies on a mixture of analysis, wisdom, experience, and judgment when making decisions. Considers all relevant factors and uses appropriate decision-making criteria and principles. Recognizes when a quick 80% solution will suffice.

• Drives Results – Consistently achieves results, even under tough circumstances. Has a strong bottom-line orientation. Persists in accomplishing objectives despite obstacles and setbacks. Has a track record of exceeding goals successfully. Pushes self and helps others achieve results.

• Ensures Accountability – Holds self and others accountable to meet commitments. Acts with a clear sense of ownership. Takes personal responsibility for decisions, actions, and failures. Establishes clear responsibilities and processes for monitoring work and measuring results. Designs feedback loops into work.

• Instills Trust – Gains the confidence and trust of others through honesty, integrity and authenticity. Follows through on commitments. Is seen as direct and truthful. Keeps confidences. Practices what he/she preaches. Shows consistency between words and actions.

MaxCyte, Inc. is an equal opportunity employer. To apply, please send your resume and cover letter . Please reference Director, Engineering Product Development in the subject line.

oct 2021