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Injection Molding Engineer II

Job typeJob offer
A job for Professional experienced
We are looking for As of now
A job at Full time
Location  Denver, PA

In the Röchling Group you’ll be shaping industry. Worldwide. Together, we are changing everyday lives – by making cars lighter, making drug packaging safer and enhancing industrial applications. With 11,000 employees in 25 countries.

In the Medical division, you will work with our customers to make pioneering contributions to disease prevention and health restoration worldwide. We offer a wide selection of custom-tailored components through to complete systems.

Your tasks:

Responsible for process engineering activities and deliverables including process development, equipment support, documentation, process implementation, problem solving, training, and process/equipment technology transfer.

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

Develop new and improve existing manufacturing processes to repeatability produce high-quality medical device components. Use technical knowledge and industry expertise to develop lean and capable manufacturing processes.

Support new product development initiatives via activities including process development, manufacturing sequence analysis, PFMEA/Quality planning requirements.

Design and/or implement improvements/new fixtures and equipment to support manufacturing processes.

Conduct and analyze process tests to understand variables and interactions. Write reports (i.e. EST’s) to document tests and results. Participate in protocol development and execution of equipment IQ, process qualifications and validations per applicable RML and external procedures/standards.

Lead projects as requested pertaining to process development, fixture development, and/or equipment implementation.

Develop process and manufacturing documentation, manufacturing operation records, and associated process documentation such as preventive maintenance procedures, maintenance logs, and Good Manufacturing Practice (GMP) records.

Utilize six-sigma quality tools, when appropriate, to define, measure, analyze, improve and control processes and outcomes.

Establishes open communications and productive relationships with individuals in all levels of the organization, customers and suppliers.

Comply with FDA, ISO and internal QSR requirements.

Provide status updates and ongoing communications to senior engineers, customers, management and team members through the use of project management tools.

Specify equipment, processes and products to meet customer requirements/specifications; determine critical process quality attributes.

Manage product/process development or improvement programs through Project Management.

Lead development technicians, toolmakers, and draftsmen on assigned projects, along with operational personnel as required.

Establish contacts with vendors and suppliers for services required.

Specify and order materials and components for process development and prototype manufacturing.

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

Assist manufacturing and industrial engineers and others with standard costing and quotations. Use Visual system to establish costing, bill of materials and operational routings.

Train production and set-up personnel as required.

Assist with customer quotation proposals for new and existing customers. Ability to determine manufacturability of customer product designs and be able to make suggestions for improvements on proposals from new and existing customers.

Knowledge in material selection of thermoplastic polymers for customer proposals.

Work with new and existing mold tool vendors for improvements or changes to existing mold tooling and for final design of new mold tooling for injection molded products.

Knowledge in design and operation for 3-D printing of holding fixtures, tool fixtures, and other simple to moderately complex devices.

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

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

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

Actively participates in the OpEx efforts of the Company.

Provide other department and manufacturing support as requested by immediate supervisor.

Other duties may be assigned.

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 five years related experience and/or training; or equivalent combination of education and experience. Five years experience in a manufacturing environment, 3 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.

Job requirements:

Laura Poole
Human Resources
+1 717 335 3700
laura.poole@roechling-medical.us

Roechling Medical Lancaster
44 Denver Road
17517 Denver, PA
United States

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