MVE Biological Solutions is the leading global manufacturer of vacuum insulated products and cryogenic systems. More than 50 years ago, they set the standard for storage of biological materials at low temperatures. Today, they continue to exceed these standards. Industries from around the world look to MVE for excellence and innovation. Their solutions empower industries to better utilize cryogenic technology. In this manner, MVE continues to make a vital contribution in today’s biomedical life sciences industry.
POSITION SUMMARY
The Engineering Manager will be responsible for leading the stainless steel freezer design engineering department at MVE’s Ball Ground, Georgia facility. The manager position will need to utilize best practice engineering methods and provide technical guidance for various engineering initiatives. Critical success factors for this role include exceptional leadership ability, continuous improvement in cost and quality, engineering project completion to plan, developing technical resources, enforcing engineering standards, and driving innovation. This position requires a unique combination of skills to support and improve current production designs as well as to incorporate acquired production designs within a medical device organization.
PRIMARY RESPONSIBILITIES (include but not limited to)
- Analyze and optimize all aspects of engineering project management, using planning, monitoring, and controlling processes to project completion on time and within budget.
- Identify and offer solutions to manage projects when issues and risks arise or to accommodate project scope changes and their impact on resources and schedules.
- Identify, lead, and/or participate in major cost improvement programs for existing products.
- Lead the development and implementation of processes where formal processes may not exist.
- Manage the engineering team resources and implement a system that ensures safety, performance, and reliability of products developed on schedule as outlined by senior management goals.
- Facilitate the use of the quality approaches such as Statistical Process Control, Root Cause Analysis, Design for Six Sigma, 80/20, 90/10, etc. to achieve and maintain product and process quality and efficiency.
- Facilitate collaborative cooperation with the Manufacturing, Embedded Electronics, Quality, Sales, Finance, and Purchasing departments to improve product quality and reliability.
- Lead the implementation of lean manufacturing and engineering techniques.
- Hiring, developing and managing a team of diverse engineers.
- Provide performance and expectation feedback and career development guidance.
- Develop budgets for design engineering activities, working closely with Project Management, Product Management, Manufacturing Management, and Senior Management.
- Manage the development process from design concept through manufacturing.
COMPETENCIES & PERSONAL ATTRIBUTES
- Strong knowledge of mechanical engineering design principles including structural, heat transfer and fluid flow.
- Working knowledge of SOLIDWORKS for component, subassembly and FNL assembly development and associated drawing generation.
- Proficient in the application of geometric dimensioning and tolerancing (ASME Y14.5) and tolerance stack-up analysis of assemblies.
- Passion for working in a values-based company in alignment with a learning organization.
- A change agent and strong collaborator who is not afraid of challenging status quo.
- A collaborative team player who embraces and champions MVE’s culture.
- Strong work ethic and ability to deliver results and meet commitments in a dynamic environment.
- Exceptional and dynamic communications skills with the ability to inspire and influence people at all levels, build consensus and commitment, and effectively drive change throughout the organization at a rate that fits the corporate culture.
- Exceptional organizational and planning skills and strong analytical abilities.
- Desire to own decisions and take responsibility for outcomes.
- Excellent personal skills in leadership, coaching, and communicating at all levels of the organization.
- Ability to manage multiple projects effectively and lead diverse groups of people.
- Experience articulating and negotiating the concise specifications of a new or revised product with all stakeholders.
- Complete understanding of and proven experience in the cradle to grave product development process from the concept and feasibility phase through design and development, design transfer, regulatory submissions and approval, product launch, and post market surveillance.
- Thorough knowledge of personal computer programs including, but not limited to, Excel, Word, Outlook, PowerPoint, Visio, SharePoint, etc.
- Demonstrated success in organizing, developing, managing, and mentoring technical personnel.
- Demonstrated success in contributing significantly to the growth of the organization.
QUALIFICATIONS AND EDUCATION REQUIREMENTS
- Bachelor’s degree in Mechanical Engineering required.
- Minimum of 2 years’ experience in engineering management and 4+ years’ of individual contributor engineering experience.
- A minimum of 3+ years’ experience in product development in a regulated industry: medical device (preferred), pharmaceutical, or aerospace.
Top Skills
What We Do
Cryoport Systems is a market leader in globally integrated temperature-controlled supply chain support for critical, irreplaceable products and materials in the Life Sciences industry. We are already trusted to support over 650 active clinical trials and we support the leading commercial therapies worldwide, delivering unparalleled, integrated supply chain services for products, therapies and treatments requiring unique, specialized temperature-controlled management. As the Life Sciences constantly evolve and advance, so do we.
