Medical Device Mechanical Design & Quality Project Engineer

Actalent; Versailles (OH); On-site; USD 66,000 - 90,000; Full time

Job summary

Actalent is seeking a Mechanical Design Project Engineer in Versailles, OH to lead cross‑functional efforts improving the quality and cost of electro‑mechanical medical devices. You will collaborate with R&D, manufacturing, service, and supply chain while serving as a subject matter expert in the quality department.

The role emphasizes Six Sigma, CRE/CQE qualifications, and hands‑on design, testing, and documentation within a regulated environment.

Qualifications

• Bachelor's Degree in Engineering or related field.
• 4+ years of product development, R&D, or design experience of electro-mechanical products.
• 4+ years of product troubleshooting and testing experience.
• Experience in root cause analysis and corrective action.
• 3D modeling/design experience.
• Experience working within a regulated market.

Responsibilities

• Ensure products and product changes comply with all specified regulatory agencies including FDA, ISO, UL, and CSA.
• Create and assist in developing, maintaining, and improving the Quality Management System (QMS) to ensure regulatory compliance.
• Drive product quality improvements internally and externally by working with design, manufacturing, and supply chain.
• Act as a technical lead, manage significant systems, use strategic planning, and mitigate risk.
• Formulate solutions to complex and ambiguous problems, incorporating feedback and solutions from others.
• Communicate complex technical ideas through daily work, presentations, and workshops.
• Foster cross-team communication and knowledge sharing.
• Collaborate with teams and management to make critical technical decisions aligning with organizational goals.
• Champion six sigma techniques and drive standardization through continuous improvement.
• Identify and manage Six Sigma projects internally, externally, and with suppliers.
• Provide leadership, coaching, and mentoring to the co-op group and engineers at various levels.
• Support, lead, or manage front room and/or back room for internal and external QMS audits and investigations.
• Teach and provide guidance on engineering documentation such as engineering drawings, bills of materials, change orders, testing documents, and DHF/DMR records.

Skills

Six Sigma experience

Root cause analysis

3D modeling

Regulatory market experience

Education

Bachelor's Degree in Engineering or related field

Certified Reliability Engineer (CRE)

Certified Quality Engineer (CQE)

Job description

Actalent is seeking a Mechanical Design Project Engineer in Versailles, OH to lead cross‑functional efforts improving the quality and cost of electro‑mechanical medical devices. You will collaborate with R&D, manufacturing, service, and supply chain while serving as a subject matter expert in the quality department.

The role emphasizes Six Sigma, CRE/CQE qualifications, and hands‑on design, testing, and documentation within a regulated environment.