SUMMARY

Responsible for process engineering activities and deliverables including process improvement and development, equipment support and maintenance, documentation, process implementation, problem solving, and training required to produce high-quality medical device components.

ESSENTIAL DUTIES AND RESPONSIBILITIES: include the following.

Maintain manufacturing equipment and assembly processes to ensure that equipment is available and ready for use by Operations.

• Work in conjunction with operators & technicians
• Develop an intimate working knowledge of equipment and processes

Write and update documents required for the operation and maintenance of manufacturing equipment and processes (i.e. OPR’s, MPS’s, PMT’s, etc.)

• Able to produce documents with minimal oversight or input
• Receive input from operators & technicians
• Ensure that the most recent procedures are documented (Continue to update as required)
• Route documents in Master Control
• Follow documents through to approval

Training – ensure that Operation’s Resources are trained on equipment and processes

• Develop Training Plan
• Train Operators
• Train Technicians

Investigate and troubleshoot any problems that arise with processes, procedures and operations related to manufacturing

• Develop experiments as necessary to understand variables and interactions
• Analyze experimental data to uncover root cause
• Communicate ideas and findings with suggestions for resolution
• Implement agreed upon Solutions
• Write reports (i.e. EST’s/CAPA’s) to document tests and results

Improve process capability and production volume while maintaining and improving quality standards

• Develop and implement metrics to monitor and improve performance of processes
• Collect data for analysis to uncover areas for improvements and innovation
• Develop and perform experimental process tests with respect to quality, methods, and cost
• Design and/or implement improvements/new fixtures and equipment to support manufacturing processes
• Create and develop new procedures for processes
• Implement solutions to improve production throughput
• Document all process changes

Assist with the early and continued development of new products and processes

• Participate in teams to assist Product/Project Engineers with the development of new products and or processes
• Assist with feasibility studies
• Assist with specifying new equipment
• Design fixtures or equipment as required
• Perform testing and studies required to establish parameters and processes
• Assist to implement equipment, fixtures, and processes into manufacturing

Assist with the implementation of new equipment and processes

• Participate in protocol development and execution of equipment FAT, SAT, and IQ’s
• Process qualifications and validations (OQ’s & PQ’s)
• Assist with establishing parameters and processes
• Development necessary documentations

Use SolidWorks or similar CAD program to design simple to moderately complex fixtures and electro mechanical systems.

Keep active ongoing project/task list that align with business needs and as assigned

• Estimated completion dates of activities
• Provide status updates and ongoing communications with management and team members

Other duties may be assigned

General

Provide leadership through:

• Good verbal communication
• Actions
• Attitudes
• Behaviors

Comply with FDA, ISO and internal QSR requirements

Enforce and contribute to a culture of safety and GMP compliance through technical specifications, training and awareness of standards and regulations.

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

SUPERVISORY RESPONSIBILITIES This position has no supervisory responsibilities

QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below 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 in a related engineering curriculum; and a minimum of three years related experience and/or training; or equivalent combination of education and experience. Three year experience in a manufacturing environment, 2 of which in medical device manufacturing. At least 3 years experience working in teams with 1 year in team leadership. Working knowledge and experience with advanced principles of tolerances, pressures, electricity, temperature, strength of materials, machine elements and other physical properties. Working knowledge of Solidworks, with ability to generate solid model and 2-D print of simple geometry.

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.

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 stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing 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 exposed to moving mechanical parts. The employee is occasionally exposed to wet and/or humid conditions, fumes or airborne particles, and vibration. The noise level in the work environment is usually loud.

COMPUTER SKILLS To perform this job successfully, an individual should have knowledge of SolidWorks Design software; Visual manufacturing software; Microsoft Project management software; Excel Spreadsheet software and Word processing software.

CERTIFICATES, LICENSES, REGISTRATIONS Six-Sigma Greenbelt

ADDITIONAL COMPETENCIES To perform the job successfully, an individual should demonstrate the following competencies:

• Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
• Project Management - Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities.
• Technical Skills - Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
• Customer Service - Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.
• Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
• Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
• Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
• Visionary Leadership - Displays passion and optimism; Inspires respect and trust; Mobilizes others to fulfill the vision; Provides vision and inspiration to peers and subordinates.
• Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results.
• Delegation - Delegates work assignments; Matches the responsibility to the person; Gives authority to work independently; Sets expectations and monitors delegated activities; Provides recognition for results.
• Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
• Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes self available to staff; Provides regular performance feedback; Develops subordinates' skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills.
• Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
• Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Aligns work with strategic goals.
• Cost Consciousness - Works within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue; Conserves organizational resources.
• Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce.
• Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
• Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
• Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Identifies external threats and opportunities; Adapts strategy to changing conditions.
• Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
• Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
• Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
• Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
• Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
• Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
• Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
• Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
• Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
• Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
• Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.

EOE/M/F/Vet/Disability