Engineering Manager

Exalta Group•Bethlehem, PA

4d•Onsite

About The Position

The Engineering Manager will lead a team of Manufacturing Engineers and Operations Specialists (CNC Programmers) across sustaining operations and new product integration to drive operational excellence. This role is responsible for optimizing production processes, supporting new product introductions, and ensuring seamless integration from design to full-scale manufacturing. The Engineering Manager will play a critical role in developing advanced machining strategies, implementing robust processes, and fostering cross-functional collaboration to deliver high-quality, compliant, and cost-effective products. Key responsibilities include project management, budget oversight, team development, technical leadership, continuous improvement, while fostering innovation to align with business objectives. This position is critical in helping EXALTA maximize the number of patients served while maintaining a high level of quality and safety.

Requirements

Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Engineering Technology, or a related field (ABET-accredited program preferred) and 10+ years of experience in the medical device/MedTech or other highly regulated industry, or Master’s degree in Biomedical Engineering, Mechanical Engineering, Engineering Technology, or a related field with 5+ years of experience in the medical device/MedTech or similar industry
Strong knowledge of CNC programming, machining strategies, and manufacturing technologies.
Expertise in process development, validation, and documentation in a regulated industry (FDA, ISO 13485).
Experience with CAD/CAM software and manufacturing execution systems.
Proficiency in lean manufacturing, Six Sigma, and root cause analysis.
Knowledge of materials, tooling, and medical device manufacturing processes.
Strong understanding of new product introduction (NPI) methodologies.
Strong expertise with Microsoft Office Suite, including Excel and PowerPoint
Strategic leadership with the ability to set vision and direction for the engineering team.
Strong communication skills with the ability to influence across functions and levels.
Analytical and problem-solving mindset with a focus on practical, data-driven solutions.
Collaborative approach, fostering teamwork and cross-functional partnerships.
Adaptability and resilience in a fast-paced, highly regulated environment.
Commitment to quality, compliance, and continuous improvement.

Nice To Haves

Black Belt or Six Sigma certification preferred

Responsibilities

Lead, mentor, and develop a high-performing team of Manufacturing Engineers and CNC Programmers.
Set clear goals, provide coaching, and foster a culture of accountability, innovation, and continuous improvement.
Develop, implement, and optimize manufacturing processes to improve efficiency, quality, and scalability.
Partner with Quality and Operations to ensure processes comply with regulatory standards (FDA, ISO 13485).
Implement lean manufacturing and continuous improvement methodologies.
Development of new manufacturing methods/process to ensure financially viable and management of the associated capital expenditures (CapEx).
Collaborate with R&D and product development teams to ensure smooth transition from prototype to production.
Establish process validation protocols (IQ/OQ/PQ) and support risk management activities.
Drive design-for-manufacturability initiatives to reduce time-to-market and improve reliability.
Oversee CNC programming strategies for precision machining of complex medical components.
Implement advanced machining techniques and tooling strategies to achieve high precision and efficiency.
Provide applications engineering support to production teams, troubleshooting process issues and driving solutions.
Work closely with Quality, Supply Chain, and Production teams to meet customer and business requirements.
Partner with regulatory and compliance teams to ensure adherence to industry standards.
Support external and internal audits as a technical representative.