SUMMARY

Responsible for manufacturing engineering activities associated with assigned technology / product lines, including: quoting, process & equipment development and maintenance, documentation, qualifications and validations, training and technology transfer, improvements, hands-on assistance, project management and process innovation.

ESSENTIAL DUTIES AND RESPONSIBILITIES: include the following. Other duties may be assigned.

Collaborates with Engineering, Quality, Supply Chain, Manufacturing, Finance, & Sales to create quotes, designs, drawings, processes, and work instructions. Acts as a subject matter expert for manufacturing processes.

Performs design reviews that incorporate a detail-oriented perspective on the impact of specific, dimensional accuracy and overall integrity of produced parts, components, sub-assemblies, and finished medical devices.

Develops, implements, and maintains methods & routings in the fabrication and assembly of parts, components, sub-assemblies, and final medical devices.

Estimates manufacturing cost using time standards and makes recommendations for tooling and process requirements of new or existing product lines.

Participates in analysis, reviews, & transfers to manufacturing as it relates to development of the manufacturing processes, post processing development, equipment and process validations, process definition for machine operation and maintenance requirements, test/inspection methods, fixturing, gauges and applying inspection and process control techniques.

Drives implementation of manufacturing processes that require qualification and/or validation of new equipment or processes. Creates and/or collaborates on PFEMA, IQ, OQ & PQ compliant with existing SOP's.

Manages and works on projects.

Maintains records and reporting systems for coordination of manufacturing operations.

Develops and leverages knowledge to assist the production department to become more efficient. This individual works cross functionally with managers, engineers, technicians, and operators to ensure programs and products run smoothly.

Conducts training sessions with new employees, carries out on-the-job training as associated with assigned product line responsibility.

Sets up and operates production equipment as needed to either troubleshoot programs, prove out processes or perform engineering studies.

Solve maintenance problems and implement solutions as associated with assigned product lines.

Collaborates with suppliers or vendors on technical issues and new product introductions.

Executes Engineering Change Process and implements process updates and improvement efforts.

Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to role.

Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties

Maintain communication with manufacturing on established products concerning changes, revisions, problems, and improvements and take necessary actions.

Adhere to all Company policies, rules, procedures, and housekeeping standards.

Follows the official policy for Good Manufacturing Practices as required in the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act.

Other duties may be assigned.

SUPERVISORY RESPONSIBILITIES

Indirectly supervises project team ranging from 1 to approximately 15 employees.

QUALIFICATIONS

To perform this job successfully, an individual must beable to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

Bachelor's degree (BS) from four-year college or university; or fifteen years related experience and/or training; or equivalent combination of education and experience. Additionally,

3-5 years of experience with CAD/CAM software and tooling to create CNC programs

Demonstrated ability and fluency in print reading and GD&T, Statistical Process Control, Lean Manufacturing, Six Sigma, and Gage/fixture design

Demonstrated expertise in production processing.

Capable of utilizing inspection equipment to verify products.

Demonstrated ability to implement, maintain, analyze and react to various production performance metrics and KPIs

LANGUAGE SKILLS

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write training programs. Ability to effectively present information to top management, groups of employees, and/or boards of directors.

MATHEMATICAL SKILLS

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

REASONING ABILITY

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

CERTIFICATES, LICENSES, REGISTRATIONS

Lean, Six Sigma. Certified in Project Management is a plus

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to stand, walk, and talk or hear. The employee is occasionally required to sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; and stoo

Roechling Medical Lancaster, LLC

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