SalaryUSD $100000.00 - $120000.00 per hour 100000.00 - 120000.00 per hour
SourceAdvantage Technical Resourcing
Product Development EngineerEducation: Bachelor's degree in Engineering Experience: Minimum year of related experience: 5+ years or 4+ years with MS or 0-2 years with PhD.Skills/Competencies/Other considerations:
- Experience in Medical Device development and/or sustaining engineering efforts utilizing a stage-gate process. .
- Working knowledge of, and experience in applying, FDA Design Controls and international standards (e.g., Design Controls, 820-CFR, ISO14971, ISO10993, IEC60601, GMP, etc.).
- Capable of leading & developing many of the Design Control deliverables required to document a product design and establish compliance with Design Inputs with appropriate specificity and quality.
- Proficient in Microsoft Windows Office applications including MS Outlook, MS PowerPoint, MS Project, Visio, etc
- SolidWorks working knowledge and experience in developing efficient / manufacturable designs. Proficient in the creation and critical review of engineering drawings (appropriate tolerances) and tolerance analysis. Knowledge of common manufacturing methodologies, technologies, and materials employed in medical devices.
- Must be able to solve complicated technical challenges and use good judgement in making timely decisions.
- Experience in the practical application of statistics and working knowledge of a statistical analysis package (Minitab).
- Must be able to communicate effectively, both verbally and in writing.
- Comfortable presenting information to team members and stakeholders.
- Responsibilities: Provides technical leadership, and/or significant contributions, to product development projects and/or technology development efforts.
- Contributes to all aspects of product development activities and product Design History Files, such as; requirements creation/documentation, ideation / prototyping, design / development documentation, technical risk mitigation, verification testing and reports, design validation studies, risk management documentation, design reviews, and supports the compilation of documents to enable regulatory submissions.
- Develops engineering solutions and innovations, collaborates with company IP Attorneys as needed.
- Supports or leads efforts to evaluate and identify design solutions which will meet product/performance requirements, cost targets, and manufacturability requirements.
- Develops verification and validation testing strategies, authors testing protocols and reports, and ensures products meet and/or exceed established specifications.
- Maintains an understanding of applicable industry guidance documents and testing standards and ensures appropriate consideration and compliance.
- Employs statistical techniques to establish exceptional product quality, reliability, and robustness.
- Supports in ensuring product and performance specifications are appropriate and accurate.
- Supports and/or directs internal and external design partners, suppliers and manufacturers as needed.
- Leads and/or supports testing to support marketing collateral, training programs, and launch activities.
- Provides regular updates to engineering and marketing leadership on product status and advancement.