The Manufacturing Engineer will provide technical leadership for all aspects of manufacturing engineering throughout the product realization process. The purpose of this position is to select appropriate suppliers, while developing and improving in-house and supplier manufacturing processes. The Manufacturing Engineer provides a key role to ensure product is built to defined procedures, specifications and requirements. This position will lead and participate in process validation (IQ/OQ/PQ) activities, and will assist as needed with development through manufacture, and supplier management activities.
- Thorough understanding of medical device manufacturing with respect to Good Manufacturing Practices (GMP).
- Assure conformance of processes during the manufacture, and quality control operations with approved procedures, Quality System Regulations (FDA 21 CFR 820), ISO 13485, Canadian Medical Device Requirements (CMDR), MDD 2007/47/EC, and other applicable international standards and regulations.
- Thorough understanding of Design Master Records, Design History Records, and Bill of Materials/product structure.
- Selects, develops and improves manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors and suppliers.
- Leads and participates in IQ/OQ/PQ activities, test sample size selection, test method validations, Gauge R&R studies and Process FMEA activities to assure conformance to product quality standards and applicable regulations.
- Assures product and process quality by designing testing and acceptance methods; testing finished- product and process capabilities; establishing standards; conferring with equipment vendors and suppliers.
- Provides manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements.
- Prepares product and process reports by collecting, analyzing, and summarizing information and trends.
- Participates in problem solving activities and failure investigations related to manufacture, inspection, and testing â€“ including CAPA, NCRs, and supplier related issues.
- Lead and participate in supplier audits, supplier evaluations and supplier performance reviews.
- Communicates significant issues or developments, provides plans, and recommendations to the team and management for resolution.
- Provide training and direction as required to other associates.
- Participates in development activities as needed.
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.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formula, scientific equations, graphs, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.
- Bachelor’s and/ or Master’s degree in Engineering or Science discipline.
- Degree in Biomedical, Manufacturing, or Mechanical Engineering preferred.
- SME certified Manufacturing Engineer a plus.
- Minimum 3-7 years in the medical device industry.
- Demonstrated knowledge of FDA quality system regulations and ISO 13485, FMEAs, DOE, CAPA, Risk Management, Failure Investigations, Process Validations, etc.
- Knowledge of engineering drafting programs useful (e.g. solid works or pro engineer)
- Experience with medical device manufacturing Quality Assurance/ Regulatory Compliance, principles, and systems
- Experience in the use of a product life cycle management system.
To perform this job successfully, an individual should have experience in the use of MS Office (Word, Excel, and PowerPoint)
Knowledge, Skills and Other Abilities
- Outstanding problem solving skills
- Ability to speak effectively before groups or management
- Strong written, verbal, analytical, and interpersonal skills
- Self-motivated, team player, multitasking ability, time management and organization skills
- Ability to work in fast paced environment with minimal direction or supervision provided
- Ability to interpret FDA, ISO regulations and prepare systems to meet those requirements
- Thorough knowledge of statistical analysis, reliability, maintainability, and risk management, include key terms and definitions, modeling, system design, assessment tools and reporting
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 regularly required to sit, use hands, and talk or hear. The employee is frequently required to stand, walk, and reach with hands and arms. The employee is occasionally required to climb or balance, and stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move up to 10 pounds. They also occasionally move objects weighing up to 20 lbs., and sometimes, but rarely, up to 50 lbs. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to see color.
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 occasionally exposed to work near moving mechanical parts. The employee is occasionally exposed to fumes or airborne particles, and risk of electrical shock.
The noise level in the work environment is usually mild to moderate.
Minimal, as neededApply