Job Summary

The Manufacturing Engineer is responsible for leading advanced manufacturing processes, driving process improvements, and ensuring the highest quality standards in the production of orthopedic implants and instruments. This role provides technical expertise, strategic leadership, and hands-on support for process development, automation, and validation while collaborating with cross-functional teams to optimize manufacturing operations.

Responsibilities

Manufacturing Process Development & Optimization:

• Design, develop, and implement cutting-edge manufacturing processes for orthopedic implants and surgical instruments.
• Lead process validation (IQ, OQ, PQ), ensuring compliance with FDA, ISO 13485, and GMP regulations.
• Identify and implement automation, robotics, and advanced machining solutions to enhance efficiency.
• Optimize CNC machining, and additive manufacturing processes for cost-effective and high-quality manufacturing/production.
• Develop work instructions, standard operating procedures (SOPs), and process flow documentation to support manufacturing/production.

Continuous Improvement & Lean Manufacturing:

• Drive Lean Six Sigma, Kaizen, and 5S initiatives to enhance productivity, reduce waste, and improve process reliability.
• Lead root cause analysis and Corrective/Preventive Action (CAPA) implementation to resolve manufacturing issues.
• Develop and execute strategies to reduce cycle times, scrap rates, and production costs while maintaining quality standards.

Equipment, Tooling, & Technology Advancement:

• Oversee selection, installation, and validation of state-of-the-art manufacturing equipment and tooling.
• Work closely with R&D and product development teams to ensure design for manufacturability (DFM) and design for assembly (DFA).
• Collaborate with suppliers and vendors to identify new materials, coatings, and machining technologies for orthopedic applications.

Regulatory Compliance & Quality Assurance:

• Ensure all manufacturing processes comply with FDA, ISO 13485, and GMP standards.
• Partner with Quality and Regulatory teams to support audits, inspections, and process documentation.
• Utilize statistical process control (SPC) and data-driven decision-making to maintain product integrity.

Leadership & Mentorship:

• Provide technical leadership and mentorship to junior engineers and manufacturing teams.
• Serve as a subject matter expert (SME) in manufacturing engineering, troubleshooting complex production challenges.
• Collaborate with cross-functional teams, including R&D, Quality, and Supply Chain, to drive innovation and efficiency.

Requirements

• Education: Bachelor’s or Master’s degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or related field
• Experience: Minimum of 3 (??) years in manufacturing engineering, preferably in the orthopedic or medical device industry.
• Technical Skills:
• Expertise in CNC machining, additive manufacturing (3D printing), and precision assembly.
• Proficiency in CAD/CAM software (SolidWorks, Mastercam, SmartCam, or similar).
• Strong background in process validation, statistical analysis, and DOE (Design of Experiments).
• Experience with automation, and robotics
• Certifications (Preferred): Lean Six Sigma Black Belt, PMP, or equivalent industry certifications.
• Soft Skills: Strong analytical skills, leadership, problem-solving, and effective communication abilities.

About Onkos

At Onkos Surgical, we believe individuals with cancer requiring surgery deserve solutions designed specifically for them. These individuals, their caregivers and their support network deserve an organization passionately championing their cause.

At Onkos Surgical, we exist to maintain a singular focus on surgical oncology by looking at everything we do through the lens of the cancer surgeon and their patients.

At Onkos Surgical, we will:

• Find solutions to our patients’ unmet clinical needs and advocate for their cause.
• Partner with surgical oncologists through research, education and innovation, to treat their patients more effectively and more efficiently.
• Collaborate with regulatory agencies to find pathways to provide timely solutions while upholding the highest standards of quality or compliance.
• Fulfill our employees’ desire to make a difference in the lives of the patients they serve while achieving their own professional growth.
• Deliver value to our customers and shareholders.