Job Description
Job DescriptionDescription:
Manufacturing Process Engineer
Full-time | Permanent | Salaried
*We are not currently working with third party agencies on this role.
About Us:
Vantedge Medical is the premier metals-based med-tech solutions partner from concept to full-scale manufacturing. We are at the forefront of precision engineering and innovation, specializing in the development and manufacturing of vital components for medical markets such as Robotic Assisted Surgery, Orthopedics, Surgical Instruments, Dental, and more. Our teams work in unison, collaborating and problem-solving to serve the manufacturing needs of the top Medical Original Equipment Manufacturers (OEMs) around the globe. Making a difference in the lives of patients and their families drives us to go above and beyond every day. With a steadfast commitment to advancing medical technology, we take immense pride in the work we do – and have a lot of fun doing it.
About this Opportunity:
This position will plan, conduct and coordinate all process engineering functions pertaining to manufacturing. The MPE will be responsible for operational excellence and quality through efficient Cell design. The MPE will ensure continuous improvement in process, quality and production.
The MPE will work with Engineering, Customer Service, Machinists, Sales, Supply Chain, Quoting and the Customer to verify and validate that the product being developed meets the customer’s requirements.
Responsibilities:
- Responsible for providing process engineering in accordance with applicable industry codes and standards including detailed phases of the process engineering work, related documentation, and field support, as well as coordination of work with customer and suppliers.
- Develop work instructions, manufacturing drawings, technical specifications, performance data and process checklists necessary to manufacture the product.
- Develop standard operating procedures (SOP’s) and set process parameters.
- Design fixtures to be used in manufacturing and quality.
- Develop the quality procedures necessary to validate the product and necessary fixtures, tools or test jigs that may be needed for the manufacturing and quality process.
- Perform statistical process studies.
- Perform equipment and process validations.
- Design of experiments to identify and reduce process variation.
- Reduce waste and increase efficiency through continuous improvement and other lean tools.
- Analyze trends in equipment issues and implement corrective actions.
- Collect and analyze production data to improve processes.
- Engineering technical assistance and support for process improvement efforts for operating Cell through planning/implementing investigation and analysis.
- Proactively implements quality improvements and ensures ISO and FDA standards are met.
- Train manufacturing personnel on manufacturing procedures and quality test.
- Effectively plan, implement, control, report, and provide updates on Customer Project.
- Generate project schedules and deliver monthly status reports.
- Coordinate with team members to ensure effective use of internal resources.
- Oversee project deliverables with cross functional teams to support milestone completion.
- Provide customer advocacy within Omni and strive to exceed customer expectations.
- Effectively communicate client expectations and information to internal and external teams.
- Maintain high quality standards through inspection and performance testing plans, compiling final document records and assisting with the development of project management processes, systems, standards and continuous improvement project within the Cell.
- Ability to quantify and mitigate project risk.
- Deliver projects in accordance with the customer specification and Omni’s standards, budget & schedules without compromising quality.
- Work diligently to troubleshoot problems with production and take corrective action.
- Involvement in cost reduction, quoting, capital projects and material/process improvement projects.
- Special projects as needed to support operations and our customers including those which require additional work hours, travel and training.
Requirements:
- Bachelor’s Degree in Mechanical/Industrial Engineering or other related field.
- 4+ years experience of related experience.
- Read, understand and interpret blueprints including application of GD&T.
- Technical knowledge of medical and orthopedic precision machined parts technology such as production systems, quality/sterilization, packaging and equipment design and application a plus.
- Solid understanding of contract language, project planning, technical scope interpretation, schedule management and attention to detail is critical for success in this role.
- Technical experience within ISO and FDA regulated industry.
- Team-focus, project ownership and customer commitment.
- Must have a sense of urgency and be very detail-oriented
- Strong problem solving and root cause analysis skills.
- Strong technical communication (verbal, written, presentation) skills.
- Professionalism and commitment to quality and customer service.
- The ability to work in a team environment, possess skills in leading technical decision making and resolution of issues, eagerness to learn and relate to co-workers.
- A high energy level and drive to finish out projects or issues even when faced with obstacles or setbacks.
- Ability to influence/persuade others.
- Displays a high moral and business code of conduct.
- Pro-active, takes initiative, energetic.
- Well-developed interpersonal skills.
- Proficiency with Excel, Word, Project, MS Office Suite software
- Proficiency with Solidworks
- Proficiency with SPC tools and methodology
- Ability to work extended hours as needed to support customer deadlines
- Ability to travel to customer or supplier facilities to conduct reviews, audits or qualifications.
- Excellent management and communication skills with the ability to influence customers, stakeholders, the manufacturing and project teams is essential in order to deliver projects in accordance with Omni standards, ISO, FDA regulatory requirements and exceed customer expectations.