Current Employment Opportunities
Quality Engineer
Job Posted: 3/29/2023
Summary:
As a Quality Engineer at Vascular Technology, Incorporated, you will work to improve the quality of products and processes while operating in a culture highly receptive to quality with the objective of doing the right thing. You will have the opportunity to support and provide guidance to the adherence of processes and procedures in order to maintain safety, efficacy and quality of our products and compliance with applicable standards and regulations.
Duties and Responsibilities:
- Assigned to processes and projects of moderate to high complexity, perform compliance assessments, make decisions regarding quality and regulatory requirements; ensures adherence to current regulations.
- Team participant assigned to projects related to quality initiatives and compliance improvements.
- Author new and revise existing operating procedures and test or inspection protocols and reports.
- Perform impact assessments, root cause analysis, identification and implementation of appropriate corrective actions and preventative actions.
- Perform statistical analysis/trend problem reporting data to support the site (e.g. yield improvements, CAPA, complaint and scrap reduction).
- Contribute to continual process improvement by participating in site projects.
- Facilitate risk assessments, FMEAs for new product introduction, and take appropriate actions during quality oversight activities to ensure adequate controls in relation to the level of product quality, safety and business risks.
- Create/maintain and/or remediate Design History Files and Risk Management Files.
- Perform Supplier Change Evaluations, Internal Change Evaluations, Product Quality Reviews, Customer Notifications, Field Action activities.
- Participate in new product development activities to ensure the smooth transfer from development to production.
- Support other activities within the Quality Management System as required.
- Other duties as assigned.
Preferred Qualifications:
- Working knowledge of industry standards (e.g. ISO 13485, ISO 14971, ISO 11135, ISO 60601, etc.)
- Ability to work independently or as part of a team, self- motivated, adaptable
- Excellent communication skills both verbal and written
- Strong attention to detail
- Proactive
Education/Experience:
Bachelor’s Degree in an Engineering discipline from an accredited college or university; and minimum four years’ experience in medical device industry or another highly regulated field; or equivalent combination of education and experience.
Knowledge, Skills and Other abilities:
- Knowledge of industry standards including ISO 13485 and ISO 14971 at minimum
- Knowledge of Food and Drug Administration Part 820
- Knowledge of EU MDD/MDR and other applicable country directives and regulations
R&D Engineer
Job Posted: 3/29/2023
Summary:
Acts as liaison with quality, manufacturing and sales teams to create or improve company product and develop protocols by performing the following duties.
Duties and Responsibilities:
- Conducts research and development activities for Vascular Technology on new products device/design.
- Creates new products/devices from own inception/ideas or by specific request.
- Creates new products/devices from predicate devices to be improved.
- Applies research theories, principles, and models when conducting experiments and research activities.
- Designs and creates prototypes of new devices both functional and non-functional.
- Conduct and supervise pilot builds of new devices/products.
- Analyzes prototypes and first builds, conducts product tests accordingly.
- Researches predicate devices and related indications for new devices.
- Summarizes research results and communicates findings internally.
- Support all regulatory requirements for FDA and ISO testing and related documentation requirements.
- Receives feedback on prototypes and makes necessary modification to design.
- Assesses the scope of research and budgets time accordingly.
- Develops and documents technical specs, sketches, drawings and materials required for complete design.
- Supports and contributes to VTIs intellectual property/patentable ideas organization value.
- Writing test protocols and test reports.
- Manage and upkeep of R&D lab.
- QC testing on new and current devices/products.
- Production training and supervising.
- Design and produce specific and unique tooling.
- Supports all departments where needed.
Skills:
- Oral Communication Skills
- Written Communication Skills
- Organization Planning
- Professionalism
- Project Management
- Time Management
- Diplomacy
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.
Language Ability:
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.
Math Ability:
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 apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
Computer Skills:
To perform this job successfully, an individual should have knowledge of Microsoft Word and Microsoft Excel.
Job Title: Research & Development Engineer
Reports to: Senior Director of Product Development
Assembler
Job Posted: 3/29/2023
Summary:
To assemble products in accordance with established standards by performing the following duties.
Duties and Responsibilities:
- Assembles assigned product parts on assembly line in accordance with production guidelines.
- Performs spot checks of products to ensure adherence to approved quality standards.
- Notifies management of product discrepancies or equipment malfunctions.
- Adheres to established company policies and procedures paying special attention to safety regulations.
- Wears personal protective equipment in accordance with training guidelines.
- Performs other related duties as assigned.
Skills:
- Oral Communication Skills
- Written Communication Skills
- Physical Dexterity
- Reading Skills
- Figure Aptitude
- Time Management
- Ability to lift up to pounds
- Mechanical Skills
Education/Experience:
High School Diploma or Equivalent. Prior assembly experience helpful.
Job Title: Assembler
Reports To: Production Manager
Department: Manufacturing
