Job Overview

Process development engineer with solid experience in the planning, design, and optimization of production processes in manual, semi-automated, and automated environments. Proficient in implementing improvements aimed at efficiency, quality, and operational safety, as well as in the validation and transfer of processes from development to mass production. Ability to lead multidisciplinary projects, root cause analysis, and application of continuous improvement methodologies. Expert in the design of tools and support devices that facilitate manufacturing and
ensure process repeatability. Results-oriented and committed to meeting the organization's strategic objectives.

Job Requirements

• Developing production improvements goals; recommending suggestions for improvements to management.
• Evaluating unfinished products and components; recommends quality and production improvements.
• Analyzing statistics related to production efficiency, safety measures, and resource usage research on effective ways of research with regards to cost saving.
• Designing and evaluating plans for implementing manufacturing equipment, technology and resources to meet goals
• New Product/Process development.
• Execute process and test method validation along with design, develop and qualify tooling/equipment.
• Using problem solving and DMAIC tools to solve processes and process improvements.
• New products introductions
• Manage product transfer from new product development to operations or product transfers
• from site to site.
• Develop bills of materials and assembly methods documentation while providing any training needed to technicians and assemblers.
• Team Leadership (Primary).
• An effective communicator that prepares status reports, modifies schedules, and manages project plans.
• Communicate to stakeholders, customers, and other informed of project status and/or related issues.
• Ability to coordinate a team of engineers and technicians and direct technical work.
• Coach/mentor technical topics to junior engineers and technicians during product tranfers.
• Collaborate effectively with other departments, including Quality, R&D, NPD, and Operations.
• Project Management (Supporting)
• Work with cross functional teams while being self-driven.
• Manage activities with risk to the project timelines, developing contingency plans, while outlining deliverables and milestones.
• Quality, safety and regulatory compliance (Supporting).
• Work with quality team to ensure all manufacturing processes and equipment comply with FDA regulations, ISO standards, and other relevant industry guidelines.
• Comply with safety and security procedures and report potentially unsafe conditions when using equipment and materials properly.
• Manage design requirements like Bioburden or particulates, Biocompatibility and cleanroom environments compatibility.
• Through understanding of Quality Management Systems (QMS) requirements that involve:
• Process Mapping, Manufacturing Process Instructions, DOE and Process Instructions, OQ/PQ
• Protocols and Reports, IQ/OQ Protocols and Reports, PFMEAs, MVP/MVRs.
• Medical Device New Product Development which includes process development and characterization along with equipment/fixture design and qualification and test method and process validations.

What your background should look like

• Proof knowledge in different manufacturing technologies not limited to laser, braiding, extrusions, polymer lamination, polymer bonding, adhesive application and curing, injection molding, test equipment, ballon forming, ultrasonic bonding, annealing process, 3Dprinting.
• Hands-on experience with complex steerable or multi-lumen catheter assembly development and manufacturing with that includes manufacturing technologies with mandrel design, PTFE assembly, reflow, braiding, tipping and extrusion.
• Must be well-organized, detail-oriented, with excellent oral and written communication skill
• Ability to achieve goals with effective planning and prioritization skills to meet immediate and longe-range needs with independence.
• American Visa (Desirable)
• Commitment with Quality and effectiveness
• Technical Leadership and Mentoring: Ability to guide, coach, and develop engineers and technicians.
• Advanced Analytical Thinking: Ability to break down complex problems and propose strategic solutions.
• Cross-Functional Communication: Clearly expresses technical ideas to stakeholders from different areas (PM, Quality, Production)
• 4+ years of working experience in the Medical Device Industry
• 4+ years working experience in new production development or product tranfers.
• Experience with design controls FDA regulation, GMP practices, and QSR requirements.
• Experience in technically leading a team of engineers and technicians across multiple projects.
• Bachelor’s degree in engineering, Plastics, Chemical, Biomedical or Mechanical Engineering
• preferred.
• MS Office Proficiency
• Advance English speaker

Competencies