Product Development Engineer

As a Product Development Engineer at Treace, you will handle a variety of tasks including managing design and development projects, conducting risk assessments, performing prototyping, and executing testing protocols. You'll collaborate with sales and marketing teams to ensure products meet customer needs while adhering to industry regulations.

Treace requires a Bachelor’s degree in Mechanical Engineering or a related discipline and a minimum of three years of mechanical design and manufacturing experience. Additionally, two years of direct product development experience in a regulated industry is essential.

CAD expertise is crucial for the Product Development Engineer position at Treace. Proficiency in Solidworks is preferred to create parametric models and generate ASME Y14.5 compliant prints, which are fundamental to the product development process.

In this role, you will work on major new products and enhancements that focus on the surgical treatment of bunions, particularly the Lapiplasty® System. This includes project management from concept through pilot production to final launch.

Yes, the Product Development Engineer role at Treace includes a travel requirement of 20-30%. This travel includes attending surgeon meetings, vendor site visits, and trade shows to ensure effective collaboration and project advancement.

Absolutely! When discussing your CAD experience, highlight specific projects where you utilized Solidworks to design products. Detail your process for creating parametric models and how those models adhered to ASME Y14.5 standards to ensure manufacturability.

In conducting risk assessments, I usually begin by identifying potential failure modes during the design phase, followed by evaluating their impacts. I involve cross-functional teams to bring diverse perspectives and ensure that mitigation strategies are comprehensive and effective.

One noteworthy challenge was a significant design revision late in the process. To overcome this, I coordinated with the team to revisit our timeline and enhance communication to ensure everyone was aligned. Our flexibility ultimately led to a successful product launch.

I prioritize effective time management, breaking larger tasks into manageable chunks with specific deadlines. Regularly reviewing project milestones and proactively communicating with my team helps keep everyone accountable and on track.

I view feedback as a vital tool for improvement. I actively listen to their experiences and insights, document their input, and integrate constructive criticism into the design process. This approach helps build trust and ensures that the end product meets user needs.

To ensure manufacturability and cost-effectiveness, I consult with manufacturing engineers early in the design phase and utilize DFM and DFI principles. This collaboration helps to identify potential issues and streamline production, maintaining product quality while managing costs.

Prototyping is a critical step in my product development process. It allows for hands-on testing of designs and gathering valuable feedback on functionality. I use prototypes to refine designs based on testing results, ensuring the final product meets all specifications.

I maintain a thorough documentation process, utilizing project management software to log design iterations, decisions made, and test results. Keeping organized records ensures that team members can easily reference and understand the design evolution.

I have a solid understanding of regulatory standards applicable to the medical device industry. I stay updated on ISO standards and compliance requirements to ensure that all products I work on meet industry guidelines before launch.

I am excited about the opportunity at Treace because of your commitment to innovation in medical technology. Contributing to products that improve patient outcomes and collaborating with a passionate team aligns perfectly with my career goals and values.