Job Scope and Quality Impact:
This position is responsible for contributing to the design, development and manufacturability of specific product(s) in accordance with the company’s Quality System and customer requirements. This position will ensure that assigned projects and/or product(s) are designed for technology transfer from R&D to manufacturing and facilitate improved manufacturability. This position complies with the Quality System by engaging in appropriate levels GMP/ISO test methodologies, adherence to Quality System Design Controls, and applies proper documentation skills.
General Description and Duties:
To perform this job successfully, an individual must be able to perform each essential job task satisfactorily. The tasks 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.
- Refines existing specifications, develops process improvements, creates validation testing and makes product yield enhancements and cost reductions.
- Researches and recommends vendor and material choices for product. Prepares and delivers status reports.
- Develops and implements quality inspection procedures, including sampling plans, for production level components and finished goods.
- Reviews and approves assigned controlled documents (e.g. work instructions, quality specifications, engineering specifications, procedures and validations protocols). Ensures that product documentation is in accordance with Quality System requirements.
- Maintains compliance of quality related logs and records, including but not limited to, CAPA, NCR, ASL, CAL/PM, and training.
- Establishes, implements, and maintains company Quality System in compliance with FDA, International Standards (ISO), and other regulatory agencies.
- Manages communication and acts as supporting liaison with regulatory agencies on compliance issues, including registration and licensing of facilities and regulatory agency audits and inspections.
- May work directly with the company/customer representative to determine needs in product repairs, complaints analysis and user interface. May provide assembler/operator training and contribute to the development of support materials as required.
- Researches, designs, and develops new processes and current product enhancements in accordance with Quality System requirements.
- Provides input regarding appropriate statistical methods, test methodologies, test facilities, and equipment.
Projects and Other Duties:
- Perform other duties as assigned.
- Skilled in the use of CAD software such as Auto cad, SolidWorks, and/or Pro E
- Knowledge of and exposure to product testing and data collection
- Familiar with Design Control procedures and requirements
- Knowledge of and exposure to product testing and data collection
- Ability and willingness to travel
- Ability to detail project plans effectively
- Bachelor’s degree in a relevant engineering discipline such as Biomedical Engineering, or equivalent experience.
- 3 years in medical device design or similar products, Class II or III devices preferred.
- Experience working under regulated quality systems such as cGMP’s, ISO, and the MDD.
Specific Skills, Knowledge & Behaviors
(To perform the job successfully, an individual should demonstrate the following competencies):
Supervisor Core Competencies:
- Leading Change: Develops and implements strategies and approaches for leading and managing organizational transformation at individual , functional, and enterprise levels, and influences change where needed
- Inspiring the Workforce: A compelling storyteller, motivates and engages employees at individual and group levels towards results
- Selecting & Developing Talent: Assesses, selects, coaches, mentors, provides constructive feedback, empowers and develops the workforce at individual and group levels
- Strategic thinking: Creates the vision and direction, assesses priorities, understands , analyzes, and acts upon drivers of business and operational success at a departmental, functional, and/or enterprise level
- External Industry Leadership & Knowledge: Connects with and influences health care and/or functional industry regulatory and government organizations, and understands external industry factors that impact the company and products
- Interpersonal Effectiveness: Actively seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self-awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately
- Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills
- Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals
- Prioritization: Effectively prioritizes work to ensure timely completion of work within scope
- Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope
- Continuous Improvement: Learns and uses best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self
- Problem Solving & Problem Prevention: Learns and uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention
- Accountability: Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility
Equipment Use & Abilities Required:
- Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, legal documents 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.
- Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
WORK ENVIRONMENT & PHYSICAL DEMANDS OF THE JOB:
The noise level in the work environment is usually quiet. While performing the duties of this job, the employee is regularly required to sit; use hands and fingers; talk or hear. The employee is occasionally required to reach with hands and arms and to move within and between the buildings. A computer terminal is used to access, input, and retrieve data. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision.