Sr. Application Development Engineer

Solesis•Winston-Salem, NC

15h•Onsite

About The Position

The Sr. Application Development Engineer will focus on supporting the Business Development team by fully understanding the Bioprocess application and client needs. This position will entail a full understanding of the technical capabilities of Charter Medical while working closely with the Business Development team and customers to identify key technical applications and solutions. The Sr. Application Development Engineer drives the projects that deliver innovation aligned with Charter Medical’s strategy and roadmap. They will regularly work with customers, third-party technology developers, internal operations, quality engineering, and business leaders to deliver new products and documentation in accordance with ISO 13485, 21 CFR 820, and applicable USP requirements.

Requirements

Bachelor’s degree in Engineering, Biomedical Engineering, Materials Engineering or related discipline.
Minimum seven (7) years of experience in the life science industry, preferably in a bioprocessing or biomanufacturing environment working with single-use systems and materials.
Experience managing technical projects.
Ability to understand the client’s needs, how the needs relate to the scope of the project, and how changes will affect other systems.
Ability to translate client inputs into engineering requirements based on technical skill set.
Ability to explain technical concepts to internal and external project stakeholders, including process capabilities, limitations, and areas for improvement.
Excellent interpersonal skills with proven ability to get along well with others and work in a team environment.
Experience with leading cross-functional projects to keep timelines, budget, and customer satisfaction on track.
Excellent analytical, critical thinking, and problem-solving skills.
Excellent organization and decision-making skills.
Experience in technical writing and use of statistical tools, including MiniTab.
Proficient with MS Excel, MS Word, MS Project, and MS PowerPoint.

Nice To Haves

Master’s degree or PhD preferred.

Responsibilities

Drives product development projects and activities for single-use products in the Life Sciences space in accordance with the business strategy, industry standards, and regulatory compliance.
Communicates the status of assigned projects and tasks to management and cross-functional teams.
Documents activities, experiments, trials, samples, and results in compliance with Good Documentation Practice (GDP) standards.
Identifies and pursues opportunities for intellectual property.
Facilitates virtual and in-person meetings to understand customers’ products, gather product and project requirements, and determine whether Charter Medical can support the project based on Charter’s capabilities.
Manages the CryoLab and projects with customer Design of Experiments (DOEs) and studies.
Works with Marketing to promote the CryoLab with clients and industry partners.
Writes technical white papers and collaborates with industry partners to publish and present content.
Partners with the Business Development team to provide capabilities presentations, support customer visits, and represent technical capabilities at the trade shows.