The Sustaining Project Engineer will play a key role in both current and new product development endeavors, contributing to sample product builds, evaluation, and testing. This position is pivotal in ensuring that products meet defined requirements and quality benchmarks while evaluating their alignment with customer needs in terms of functionality and usability.
Duties and Responsibilities:
Collaborate as a team member to enhance existing products, identifying opportunities for process optimization and quality improvement.
Assist in research and testing of product concepts, including documentation and monitoring of engineering R&D experiments. Upgrade older products by identifying avenues for streamlining processes and enhancing quality.
Provide ongoing product support to manufacturing, sales, and quality teams, addressing design requirements, customer needs, testing, CAPA, and product documentation.
Coordinate with manufacturing to assess design changes, optimizing them for efficient and cost-effective production.
Ensure compliance with ISO13485 standards, FDA regulations, and Good Manufacturing Processes for both new and existing product development.
Participate in technical design reviews across departments, offering technical solutions to engineering challenges using analytical methods like DOE, correlation studies, and statistical analysis.
Apply FMEA process to implement robust engineering solutions.
Validate design solutions by developing test plans, adjusting designs, conducting performance calculations, maintaining quality standards, and approving prototypes.
Support product project management from prototype to full production, adhering to accurate project schedules and budgets.
Operate within a LEAN manufacturing environment, actively suggesting process improvements.
Required Knowledge, Skills, and Abilities:
Proficiency in standard computer applications such as MS Word, Excel, Outlook, and PowerPoint.
Effective communication skills for interactions with internal and external stakeholders.
Strong teamwork abilities, understanding others' roles, and empowering team members for collective success.
Attention to detail across all job aspects.
Ability to make decisions using available resources and sound judgment.
Demonstrated problem-solving skills, with the ability to gather and analyze information skillfully.
Effective teaching, coaching, and counseling skills to support team development.
Openness to new ideas and willingness to try new approaches.
Commitment to accuracy, thoroughness, and quality monitoring.
Prioritization and planning skills to use time efficiently.
Adaptability to changing work environments and ability to manage competing demands.
Willingness to follow instructions, seek feedback, and continuously improve.
Ability to build trust with management, colleagues, and customers.
Education and Experience:
Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, or a related field, or equivalent experience.
Design and development experience in the manufacturing industry, with college internship experience considered.
Understanding and experience in product design and development, including tools such as FEA, Risk Analysis, DFMA, SUS, and GD&T.
Experience in producing machined prototypes.
Knowledge of statistical methods/analysis, including application of Six Sigma statistical analysis and controls.
Demonstrated knowledge of applied mechanical engineering in product design and evaluation.
Proficiency in 3D CAD software, with SolidWorks preferred.
Understanding of CAE tools (FEA, CFD, etc.).
Good project management skills, with Microsoft Project experience preferred.