Product Development Engineer

Advantage Technical Resourcing - Product Development Engineer

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.

At Advantage Resourcing, our primary objective is to perfectly align the best people with the appropriate jobs. These jobs may be temporary assignments or career positions. We place talented people in a wide variety of jobs working with our client companies in areas such as: engineering, IT, technical, manufacturing, skilled trades, distribution, call centers, clerical, accounting, finance and sales.Our strength is being able to solve our client's workforce needs by matching people that have the right skills, knowledge and motivation to each opportunity. Advantage Resourcing can help you discover the personal and career success you desire.Advantage Resourcing Americas, Inc. is an Equal Opportunity Employer offering employment without regard for race, color, religious creed, national origin, ancestry, gender, marital status, age, sexual orientation, sex, gender identity, disability, veteran status, or other legally protected categories. Advantage Resourcing is a VEVRAA Federal Contractor.