Position Summary: We are seeking a driven and technically adept Senior Process Engineer with a strong mechanical engineering foundation to join our R&D Hardware Engineering team. This individual will lead cross-functional projects, supporting the development and transfer of innovative medical diagnostic products from concept through to high-volume manufacturing. The ideal candidate is an excellent communicator, a proactive collaborator, and someone who thrives in a fast-paced, highly regulated environment. As a key contributor in our product development lifecycle, the Process Engineer will apply standard engineering techniques, procedures, and judgment to solve complex problems, design scalable processes, and ensure compliance with FDA and industry standards. This role demands a clear vision, strong leadership, and the ability to drive progress across functional boundaries. Key Responsibilities: Primary Functions: * Lead or contribute to technical projects with cross-functional teams, ensuring project milestones are met on schedule. * Plan, prioritize, and execute engineering tasks aligned with organizational goals. * Author and maintain clear, detailed documentation supporting design controls, product development, and manufacturing transfer. * Apply Design for Manufacturing (DFM) principles to new and existing product designs. * Support the transfer of products from R&D to high-volume manufacturing environments, ensuring scalability and quality. * Develop test methods, specifications, and fixtures for mechanical components and assemblies. * Identify product defects and outliers, documenting findings and their impacts with clarity. * Communicate technical concepts and results through presentations, written reports, and collaborative discussions. * Ensure compliance with FDA policies and internal quality standards. Secondary Functions: * Provide technical guidance or mentorship to junior engineers as needed. * Propose process or procedural improvements within the function. * Assist in schedule planning and resource allocation for engineering tasks. Required Skills & Capabilities: * Strong mechanical engineering foundation, with hands-on experience in design, test fixtures, and manufacturing processes. * Demonstrated leadership and project ownership skills, with the ability to influence cross-functional teams. * Excellent written and verbal communication skills. * Analytical mindset with experience in statistical analysis and data interpretation. * Familiarity with FDA regulations, design control, and documentation practices. * Ability to work independently and prioritize multiple projects effectively. * Proactive, solutions-oriented attitude with a passion for problem-solving and continuous improvement. Minimum Qualifications: * Bachelor's degree in Mechanical Engineering or related discipline. * 6-8 years of experience in a regulated environment, preferably medical device or diagnostics. * Proven stability in prior roles (minimum of 4-5 years with a previous employer). * Experience in New Product Introduction (NPI), including product development and transfer to manufacturing. Preferred Experience: * Experience designing and developing mechanical assemblies and test fixtures. * Prior involvement in scaling products to high-volume manufacturing. * Strong understanding of DFM principles and supplier engagement. Internal Collaboration: * Regular interaction with cross-functional teams including R&D, Quality, Regulatory, Manufacturing, and Supply Chain. This is a highly visible role offering an exciting opportunity for an engaged, motivated engineer looking to grow their career while making a real impact in the medical diagnostics space After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities. You can download it from the App Store or get it on Google Play.