Drives improvements in product design to increase robustness, reduce cost, and ensure continued product viability. Includes ensuring awareness of and actively managing component end-of-life (EOL), evolving external standards, and continued post-market feedback. The Sustaining Engineering Manager will coordinate the activities of the Sustaining Engineering group.
Duties and Responsibilities
Support product design of released products including changes related to internal requests, supplier changes, field request, obsolete components, new standard compliance and other related activities.
Evaluate and resolve causes of manufacturing yield and quality problems through structured problem solving
Leads and motivates Sustaining Engineering team whose primary responsibility is to define, implement, and improve product design.
Prepare, revise and maintain documentation required to support product improvement including engineering drawings, Bill of Materials (BOM’s) and Design History Files (DHF).
Triage corporate priorities, goals, and project lead times alongside company executives and mid-management.
Provide tactical support and project management for resource leveling of the Sustaining Engineering team.
Support and assist Engineering/R&D new product development/implementation projects.
Monitor quality of engineering drawings, BOM’s and routers.
Examine methods to reduce product cost while improving product quality.
Assure that procedures and work instructions are correct, efficient and applicable.
Oversees production tooling design, control, implementation, and maintenance.
Reviews and approves Engineering Change Orders (ECO’s) for engineering of released products.
Oversees product validation including protocol/report writing, execution, and maintenance of released products.
Maintain team project status and visibility, ensure open communication, flow defect tracking, and project scope.
Perform other work-related duties as requested, directed or assigned by management.
Interface directly with production personnel and team members.
Interact with QA/RA and external auditors during plant audits.
Develop positive relationships and communication with outside vendors.
Review, consult and communicate with executive and mid-level management as needed or recommended.
Interact, coordinate and work cooperatively with other departments as necessary.
Education and Experience
Bachelor’s degree in Mechanical, Manufacturing or Biomedical Engineering; or equivalent.
Minimum of 5-10 years’ experience as a Manufacturing or Design Engineer in the medical device or other highly regulated industry.
Minimum of 3-5 years’ experience in a functional role utilizing project management.
Experience with FDA/ISO13485 processes and procedures including implementation and audits and direct experience in product and process validation.
Technical expertise & application experience in manufacturing based applications consistent with Degree such as Advanced Computer Aided Design abilities, 3D modeling through PTC Creo Software or Solidworks, and for Test Software design & implementation.
Experienced in root cause analysis techniques and failure mode and effect analysis.
Experience with Design for Assembly and Design for Manufacturing techniques.
Knowledge, Skills and Abilities
Formal experience in product and process validation per FDA & ISO requirements.
Knowledge of material handling, manufacturing equipment and processes, assembly equipment and processes, and test methods.
Knowledge of common manufacturing processes including machining, soldering, packaging and assembly line production, and electrical test.
Ability to exercise Lean Manufacturing tools, such as SPC utilization, 5S, VSM, and Kanban.
Demonstrated project management in a fast-paced environment with ability to re-prioritize as needed.
Ability to act independently and make independent decision when needed.
Strong sense of urgency.
Ability to solve engineering problems and deal with a variety of concrete variables in situations where limited standardization may exist.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Directly supervises a team of 2-4 Sustaining Engineers/Technicians.
Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; working on product design side by side with subordinates as required; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Position primarily requires sitting, standing, talking and walking in an office environment and stooping, reaching, climbing, standing, walking and talking in a manufacturing and processing environment.
Must be able to lift up to 25 lbs. and to adhere to safety requirements.
Corrected vision and color distinction is required.
Office environment including use of computers, computer systems & programs, phones, copiers and other office equipment.
Manufacturing floor, machine shop, clean room and engineering lab with occasional exposure to elements such as odor, noise, dust, heat, cold or chemicals as well as machining tools and equipment.
Use of common Personal Protective Equipment (PPE) as appropriate and recommended.
Occasional domestic travel required.
Disclaimer: This Job Description is not intended to be all-inclusive, and may be subject to change to include new responsibilities and tasks or change existing ones as management deems necessary to meet the ongoing needs of the company.
About this company
Transonic® offers employees the chance to make a difference. As a pioneering, high tech company, employees bring flow measurement benefits to: operating rooms where intraoperative flow measurements inform surgeons; research laboratories worldwide, setting the stage for medical advances; dialysis clinics where measurements enable proactive treatment to extend the lives of patients with kidney failure. In short, Transonic flow measurement technologies save lives.
Motivated employees enjoy an opportunity for both personal growth and professional advancement in a flexible, friendly, open, working environment. The company offers an excellent benefit package, including fully paid medical insurance, along with recognition for individual initiative and accomplishment.
Transonic’s headquarters is located in cosmopolitan Ithaca, NY, home to Cornell University and Ithaca College. Located in the unsurpassed beauty of the New York Finger Lakes region; in Ithaca, rural life and recreation interface with city sophistication and world class culture.
Location/Region: Ithaca, NY