The candidate will be responsible for providing design, development, and commercial support to project teams that are developing combination drug delivery devices for parenteral pharmaceutical therapeutics . The candidate, working with senior engineers and scientists, will work independently with general direction from project teams or functional management. The work is reviewed upon completion.
Job responsibilities may include –
Device Engineering development
- Primary: Develop designs and support commercial products that provide the most cost effective, robust and reliable performance for medical devices
- Characterize device designs and important material attributes (MAs) using appropriate tools such as DOE, tolerance analyses, empirical / mechanistic modeling with Monte Carlo simulation, etc.
- Identify design input requirements, ensure compliance with standards and SOP’s and support development of control system/design transfer.
- Procure lab-scale testing equipment. Design, fabricate, and procure fixtures for device evaluation
- Review change requests associated with design of the product.
Design Controls, risk management, and cGMP for biologics, pharmaceuticals, and medical devices.
- Primary: Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes.
- Understand, implement and maintain Roche Pharma Quality Policy and Pharma Quality System (PQS) in the department.
- Use (and create and implement, if necessary) local procedures and templates ensuring alignment with current versions of quality system documents and best practices.
- Assist with resolving issues due to internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
- Create and review discrepancy, change and risk management documents for devices teams.
- Ensure compliance of training to quality systems and job-related requirements.
- Participate in and draft (as applicable) hazards analyses, design assessments, and design reviews.
Internal/External Supplier and Contract Manufacturer Collaboration
- Primary: Lead and collaborate with internal / external teams to develop and maintain existing devices
- Ensure product quality and design requirements are traced through the development process.
- Assist and support testing and evaluation performed at supplier
The job may require visual inspection, testing, and manual assembly of components and devices
- Assemble test samples.
- Inspect, sort, and test device components.
- Complete cGMP records to document builds.
Proven experience in providing engineering technical input to a team composed of internal members along with external development partners and component suppliers is required. The ability to interact at a detailed technical level with process, human factors, and industrial engineers is also an essential skill. In depth experience with design controls, test method development, and design verification methodologies is also required.
Required Qualifications and Skills –
- Advanced degree, B.S., or M.S., in engineering or related discipline, with preference for Mechanical Engineering, or the equivalent.
- 5 years of experience in industry or academia (including advanced studies) after receiving their Bachelor’s Degree.
- Experience collaborating with internal and external suppliers and providing technical support to internal cross functional teams
- Self-Starter with excellent problem solving skills
- Prior experience with Design Controls
- Drafting of device design verification protocols/reports and conducting design verification testing.
- Strong Technical expertise in mechanics/selection of materials,
- General CAD experience (Solidworks preferred – not a primary responsibility)
- Proven experience in test method validation and Gage R&R
- Experience with statistical analysis and interpretation of data.
- Familiarity with risk management tools (developments of pFMEAs, etc.).
- Highly organized, detail oriented and strong communication skills including technical report reviewing and writing.
Desired Skills –
- Experience with GD&T
- Operating Machine Shop Equipment
- Lean/Six Sigma
- Technical skills in probabilistic design, tolerance analysis and design for manufacturing and assembly
- Experience working in a highly cross functional (e.g. Matrix) and collaborative environment