Senior Engineer I - Molding Process
Arthrex
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Benefits offered by this job
Job summary
Arthrex is a global medical device company seeking a Sr. Engineer I to support molding process development and manufacturing in Ave Maria, FL. The role focuses on cost-effective, high-quality production, with responsibilities spanning design, documentation, and process validation.
The candidate will lead cross-functional projects, implement continuous improvement initiatives, and ensure adherence to regulatory and quality standards in a fast-paced manufacturing environment.
Qualifications
- Bachelor's degree in engineering is required.
- 5 years of manufacturing process improvement experience requested.
- Experience leading process improvement projects.
- Medical device manufacturing environment preferred.
- Experience in workflow optimization, work measurement, efficiencies.
- Lean Six Sigma training preferred.
Responsibilities
- Collaborate with project teams to identify issues and risks in new product development and manufacturing.
- Lead continuous improvement initiatives to enhance quality and efficiency.
- Introduce new equipment, processes, and validation strategies.
- Develop manufacturing work instructions and procedural documentation.
- Estimate production times, staffing, and costs for management decisions.
- Drive automation to reduce manual processes.
Skills
Education
Tools
Job description
Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. The ideal candidate will support the Engineering Team throughout the full life‑cycle development of Class I, II, and III medical devices—including both new product development and ongoing maintenance of released products. Responsibilities include designing, developing, implementing, and continuously improving manufacturing processes to ensure cost‑effective, high‑quality medical device production. This role will also provide manufacturing engineering expertise to create, document, and execute required procedures and technical documentation. This position is based in our Ave Maria, FL location and will work within the Molding Process Engineering Department.
- Work with project teams to identify issues and risks. During new product development integrate with Engineers, Design Engineers, Quality Engineers and the Packaging Department/and or Production Department to ensure cost effective new product development and introduction into manufacturing.
- Develop a continuous improvement culture, skill sets and tools to enhance quality and operational excellence.
- Support process improvement initiative.
- Introduce new equipment, products, and processes utilizing industry standard project management tools and techniques.
- Present process and equipment recommendations to Leadership Team with regular and timely reviews that define team roles, responsibilities, and accountability to project plans for implementation.
- Initiate new projects and be the Project Leader for key improvement initiatives, identifying best practices.
- Develop an understanding of current manufacturing processes and identify targets for improvement in transactional and operational efficiencies.
- Develop manufacturing Work Instructions.
- Provide process support on manufacturing technical issues.
- Develop action plans to achieve short and long‑range efficiency goals, select new production methods, design production fixtures, and monitor efficiencies.
- Assist with implementation of packaging design or production specifications into manufacturing.
- Monitor timelines and project deliverables to ensure adherence to approved project plans for manufacturing process development.
- Develop protocols and coordinate validation of equipment and processes.
- Stay current with methods used in the medical device industry to advance technologies.
- Investigate and test improvements for reliability and quality.
- Drive automation to replace manual processes as much as possible.
- Ensure information and documentation is consistently accurate.
- Analyze workforce utilization, space requirements, and workflow, designing layout of equipment and workspace for maximum efficiency.
- Confere with vendors to determine product specifications and arrange purchase of equipment, materials, or parts, and evaluate products according to specifications and quality standards.
- Estimate production times, staffing requirements, and related costs to provide information for management decisions.
- Apply statistical methods to estimate future manufacturing requirements and potential.
- Identify issues and risks to ensure cost‑effective new product development and introduction into manufacturing.
- May supervise other Engineering, Prototype or Programming personnel.
- Bachelor’s degree in Engineering.
- 5 years of manufacturing process improvement experience required.
- Experienced in leading process improvement projects.
- Medical device manufacturing environment preferred.
- Experience in workflow optimization, work measurement, efficiencies.
- Recognized process improvement training (Lean, Six Sigma) preferred.
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list and additional responsibilities may be assigned as required by management.
- Ability to work independently and effectively with cross‑functional teams.
- Thorough understanding of manufacturing processes.
- Detail oriented with strong analytical skills.
- Statistical Process Control (SPC) knowledge.
- Strong communication skills and ability to communicate effectively with technical and non‑technical staff.
- Experienced user of MS Office Suite and CAD.
- Experience with planning and conducting tests to validate equipment and processes.
- Experience in completing technical documentation for engineering and manufacturing.
- Familiarity with clean room practices preferred.
- SolidWorks experience preferred.
Metal cutting equipment, molding, EDM, grinding equipment, finishing equipment, printing equipment, sealing equipment and custom fixturing.
Ability to comprehend and apply language skills to the degree required to perform the job; ability to verbally communicate ideas and issues effectively to other team members and management; ability to write and record data and information as required by procedures.
Must talk or hear. Must sit, use hands and fingers to handle or feel objects, and reach with hands and arms. Must occasionally lift and/or move up to 10 pounds.
Occasionally exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock. Noise level is usually moderate.
- Medical, Dental and Vision Insurance
- Company-Provided Life Insurance
- Voluntary Life Insurance
- Flexible Spending Account (FSA)
- Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
- Matching 401(k) Retirement Plan
- Annual Bonus
- Wellness Incentive Program
- Free Onsite Medical Clinics
- Free Onsite Lunch
- Tuition Reimbursement Program
- Paid Parental Leave
- Paid Time Off
- Volunteer PTO
- Employee Assistance Provider (EAP)
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.
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