The position is responsible for supporting activities performed in support of Research & Technology, Competitive Testing and/or franchise related projects. The position will initiate, research, develop, execute and assess methods for the preparation and testing of early stage technologies and concepts that utilize structural biological proteins, traditional dressing materials and/or mechanical designs. Development of manufacturing methods/processes, complex test fixtures, dressings and therapy units and associated reporting are expected work products. The position will work collaboratively and independently as part of the Global Research & Technology group. Oversight and coordination of projects, with internal and/or external resources are a key component of this role.
- Work collaboratively with other engineers and scientist in the organization to providing high-level experience, knowledge and support to R&T efforts, competitive testing efforts, and franchise teams.
- Responsible for transferring information gleaned from experiments, concepts and technology projects to both technical and non-technical parts of the organization
- Responsible for appropriate generation and protection of intellectual property
- Responsible for appropriate input, design, coordination, implementation, analysis and reporting of NPWT device evaluations within a timely manner
- Utilize expertise to propose, investigate and develop new concept ideas utilizing structural biological proteins and any associated synthesis / processing methods
- Utilize required software tools, rapidly turn new product ideas and concepts discussed in meetings and other forums into visual or physical designs by producing sketches, 3D CAD models, visualizations or prototypes;
- Evolve and ‘reduce to practice’ ideas that have been approved for development.
- Specify, select and integrate material, fabric, mechanical and electro-mechanical components, and other materials. Work with engineers and scientists of other disciplines to integrate electronics and other technologies into the new designs.
- Assist the process of achieving approval for further development of a new product concept or technology by producing supporting documentation including presentation materials.
- Serve as technical Lead Engineer/Project Manager on R&T projects or small sub-design teams and co-ordinate project activities in the development of new designs.
- Participate in cross functional development teams, and contribute to the continuous improvement and development of the technical prowess of the business locally and globally.
- Communicate well at all technical levels including appropriately communicating technical status and issues to non-technical stakeholders.
- Participate and conduct detailed design reviews as required.
- Performs technical and record keeping duties in conformance with company and regulatory policies and standards to meet quality and accuracy requirements. This includes appropriate data analysis, quality control of entered data and creations and compilation of charts, graphs and tables.
- As a member of a project teams, contribute to team meetings, liaise with suppliers and other functions outside of the R & T group. Interact with internal resources such as lead scientists, program managements, project scientists, engineers and technicians to ensure timely and quality completion of projects.
- Interact with external resources such as vendors, suppliers contract scientists, specialist and technicians as required
- Participates in any and all reasonable work activities as may be deemed suitable and assigned by management.
- Conforms to, supports and enforces all Company policies and procedures
- Bachelors of Engineering or Bachelor of Science
- Self-starter, well organized and detailed oriented
- Proven ability to effectively communicate both verbally and in writing
- Minimum seven years of experience in or with industry, substantial relevant experience in academic settings during training may be considered in lieu of experience
- Minimum five years prototyping, developing and/or processing constructs derived from or containing structural proteins
- Previous technical leadership experience
- At least 3 years experience in 3D CAD systems
- Proven comprehensive experience in producing prototypes and associated technical documents (3D CAD models, 2D drawings) within a regulated engineering environment
- Able to demonstrate knowledge of a wide range of design and manufacturing processes and able to progress a new design from concept to production. Experience working with and developing process parameters.
- Proven ability to create and refine prototypes, test jigs and working models
- Experience with utilizing analytic chemistry methods to characterize prototypes and processing parameters
- Able to generate quality engineering drawings
- Experience performing detailed task per written protocols and documenting results. Experience working in regulatory environment and in support of writing protocols preferred.
- Command of computer applications for documentation and data management (Excel, Word, PowerPoint, etc.). Experience with graphing and statistical packages, Adobe Photoshop, Sigma Scan, and Image Pro a plus.
- Demonstrated ability to create intellectual property
- Ability to deal effectively with all employees and external business contacts while conveying a positive, service oriented attitude.
- Ability to maintain complete confidentiality and discretion in business relationships and exercise sound business judgment.
- Degrees in materials science/ engineering, mechanical engineering, chemical engineering, bioengineering, protein chemistry
- MS, EIT, PE and/or PMP Certification
- Five years industrial experience in development of medical devices, pharmaceutical or combination devices
- Knowledge of FDA/ISO requirements
- Knowledge of wound management products
- Knowledge or experience processing structural proteins such as collagen, keratin, fibrin, silk, etc. and/or polysaccharides
- Knowledge or experience with fluid transport and/or hydraulics a plus
- Experience with successfully commercializing medical devices