BD (Becton, Dickinson and Company) Staff Optical Engineer - Manufacturing in Sparks, Maryland
Job Description SummaryDevelops, implements and maintains methods, operation sequence and processes in the manufacture or fabrication sub-assemblies and final optical assemblies. Interfaces with cross functional teams in coordinating the release of new products. Estimates manufacturing cost, and makes recommendations for tooling and process requirements of new or existing product lines.
Provide technical expertise and leadership related to optical products in the solution of difficult production, product, and process problems, especially at the system level.
Resolution of these problems requires expert knowledge of optical subsystems and their interactions in the fabrication, integration, test, and operation of finished systems.
Document solutions and train others as needed.
Co-ordinates and manages manufacturing processes to fulfill design intent per released Engineering documentation.
Creates and maintains comprehensive assembly/test instructions for all products; trains production associates and/or supervisors on these methods and any data records that need entered.
Analyzes and plans workflow and space requirements; determines assembly tooling, and test fixture and program needs.
Designs assembly tooling and text fixtures where needed.
Supports evaluation of potential and existing contract manufacturers to determine viability as a provider of manufacturing services.
Ensures the systems and processes used in manufacturing areas support the quality and delivery expectations of the Company.
Works with R&D Engineering during the product design phase to provide input dealing with manufacturability needs; analyzes the manufacturability of the prototype designs and refines as necessary; operates as a member of the product development team.
Participates in prototype assembly and test.
Supports selection of manufacturing part suppliers and evaluates and co-ordinates associated tooling needs.
Investigates and assists in resolving manufacturing concerns relating to production, quality and product design; may assist with design changes
Good leadership skills
Ability to communicate effectively both orally and in writing Good interpersonal skills Good analytical and problem-solving skills Good organizational skills; attention to detail
Thorough understanding of computer operations; knowledge of Microsoft Office applications and mechanical CAD knowledge (SolidWorks preferred
Detailed design work of subsystems and components of instrumentation, using a 3D CAD (Computer Aided Design) system in accordance with department procedures, to fulfill engineering requirements. Apply fabrication process knowledge to ensure manufacturability of the subsystem and components.
CAPA Execution - Understanding of the process and ability to complete CAPA activities with little guidance from the subject matter experts (SME)
Generate engineering drawings and specifications to BD standards, including ASME Y14.5M-1994 (American Society of Mechanical Engineers) Dimensioning and Tolerancing.
Conform to the requirements of ISO 9001 (International Organization for Standardization) and cGMP (current Good Manufacturing Practices) standards for the design and development of medical devices.
Masters degree in Optical Engineering or related engineering field and minimum of 7 years experience working as Optical Engineer; or Bachelors degree in Optical Engineering or related engineering field and minimum of 15 years experience working as Optical Engineer.
Must have experience working in a FDA regulated environment or highly regulated industry.
Ability to demonstrate the application of fundamental optical engineering principles and techniques.
Fluent in the understanding & application of Geometric Tolerancing
Technical Writing skills as applied to manufacturing documentation and process development
Experienced in the creation and revision of technical documentation.
Agency Compliance (General knowledge) - Familiar with general UL, CSA, CE, and RoHS requirements.
Solid Modeling and drafting experience using SolidWorks preferred
Troubleshooting skills relating to electro-mechanical assemblies
Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status
Primary Work LocationUSA MD - Baltimore
Work ShiftUS BD 1st Shift 8am-5pm (United States of America)
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.