Manager, Product Development Engineering

Solesis•Quakertown, PA

19h

About The Position

About the role: The Manager, Product Development is responsible for overseeing the successful development, transfer and life cycle management of new products, existing development products and new technologies to ensure successful production and release of clinical and commercial materials. The Manager, Product Development leads a cross-functional team that drives the development of new biomedical and textile components for use in medical devices. This position has an integral role in working with clients to understand their business needs and develop solutions while working closely with the Business Development and Business Management groups. What you will do: Manages the Product Development team to ensure manufacturability, minimize risks and optimize costs associated with products. Coaches, mentors and develops Product Engineers and Design Engineers, providing product and process engineering expertise. Manages complex departmental and cross-functional projects associated with the development and introduction of new products. Oversees the design and development of various biomaterial solutions for medical devices through collaboration with device engineers and R&D teams. Partners with a cross-functional team consisting of Quality and Manufacturing Engineering and Operations to create and document a manufacturing process that is scalable to a production environment based on client design and volume requirements and that meets the requirements outlined in ISO13485 and FDA 21 CFR 820.3. Interacts technically with clients to understand requirements in order to create a product to meet design input requirements. Responsible for documenting all phases of the development & manufacturing process according to ISO 13485 standards and FDA 21 CFR 820 regulations, including design output documentation, Verification/Validation protocols, design history file etc. Maintains a working knowledge of new technologies which may improve operations and develops recommendations accordingly. Evaluates and improves manufacturing methods, utilizing knowledge of product design, materials and parts, fabrication processes, automation, tooling, production equipment capabilities, assembly methods and quality control standards. Interacts and trains technicians responsible for executing processes required to manufacture product. Creates the department budgeting process and monitors and controls expenses through the year to meet budget requirements. Identifies staffing requirements, participates in the selection and hiring process; interviews applicants and makes hire recommendations.

Requirements

Bachelor’s degree with a concentration in Textile, Biomedical or Industrial Engineering.
A minimum of seven (7) years related experience in a manufacturing or process/project related engineering role, preferably in the medical device, textile or pharmaceutical industry.
Strong organizational skills with exceptional time management.
Ability to manage a technical project, understanding the client’s needs, how the needs relate to the scope of the project and how changes will affect other systems.
Excellent verbal and written communication skills.
Ability to independently prioritize and execute projects and responsibilities.
Familiar with ISO 13485 and FDA Design Control
Ability to lead technical projects and participate in strategic discussions amongst peers, management, clients and/or contractors.
Recommends and justifies improvements to technical capabilities, methods, and procedures.
Considerable knowledge of a variety of textile and/or medical device manufacturing techniques.

Responsibilities

Manages the Product Development team to ensure manufacturability, minimize risks and optimize costs associated with products.
Coaches, mentors and develops Product Engineers and Design Engineers, providing product and process engineering expertise.
Manages complex departmental and cross-functional projects associated with the development and introduction of new products.
Oversees the design and development of various biomaterial solutions for medical devices through collaboration with device engineers and R&D teams.
Partners with a cross-functional team consisting of Quality and Manufacturing Engineering and Operations to create and document a manufacturing process that is scalable to a production environment based on client design and volume requirements and that meets the requirements outlined in ISO13485 and FDA 21 CFR 820.3.
Interacts technically with clients to understand requirements in order to create a product to meet design input requirements.
Responsible for documenting all phases of the development & manufacturing process according to ISO 13485 standards and FDA 21 CFR 820 regulations, including design output documentation, Verification/Validation protocols, design history file etc.
Maintains a working knowledge of new technologies which may improve operations and develops recommendations accordingly.
Evaluates and improves manufacturing methods, utilizing knowledge of product design, materials and parts, fabrication processes, automation, tooling, production equipment capabilities, assembly methods and quality control standards.
Interacts and trains technicians responsible for executing processes required to manufacture product.
Creates the department budgeting process and monitors and controls expenses through the year to meet budget requirements.
Identifies staffing requirements, participates in the selection and hiring process; interviews applicants and makes hire recommendations.