Job Title: Senior Mechanical Designer
Reports To: Manufacturing Engineering Manager
FLSA Status: Exempt
Department: Operations

Summary: Designs and analyzes electro-mechanical systems, fixtures, equipment and packaging. Designs and analyzes disposable components . Creates and modifies detailed drawings using CAD hardware and software.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Designs components and assemblies for electro-mechanically complex instruments, fixtures, and disposables. Concieves , develops and refines design concepts.
• Uses SolidWorks to design and document electro-mechanical parts and assemblies as well as disposable components.
• Maintains SolidWorks vault (may include SolidWorks administration). Maintains an organized database of design work using SolidWorks.
• As required, assembles and tests parts and sub-assemblies. May perform post­ mortem analyses.
• Produces detailed fabrication and assembly drawings for use by suppliers, Quality Assurance and Manufacturing.
• Actively participates in design reviews; may lead design reviews.
• Participate in unit and system led verification activities (creating and executing test procedures, writing reports).
• Participate in the creation and maintenance of fixture/equipment files.
• Participate and provide feedback during equipment or process validations (creating and executing test procedures, writing reports).
• May participate in project planning and lead development activities.

Knowledge, Skill and Competency Requirements:
To perform the job successfully, an individual should demonstrate the following knowledge, skills and competencies:

• Minimum of 7 years medical device design experience is required.
• Expert in SolidWorks to include:
5 years recent experience (SolidWorks preferred).
Advanced parts modeling, including sweeps, lofts, multi-body models, patterns, ribs, shells, drafts, etc.
Experience maintaining “master assembly models” of complete projects with parts and sub-assemblies mated for intelligent deconstruction.
Advanced sketching techniques, and the ability to select and use references to reflect design intent.
Surfacing experience sufficient to design simple curvilinear enclosures for SLA prototyping, or to receive and manipulate designs from Industrial Design consultants.
Injection molded, cast, thermoformed and similar parts is a plus.
Experience using Workgroup PDM on a daily basis. Familiar with version and lifecycle control.

• History of successful designs of electro-mechanical devices, including:
Use of plastics, stainless steels, aluminum and engineering polymers, etc.
Fasteners, bearings, keys, shafts, etc.
Basic machining methods, clearance and interference
Design of high-volume structural or enclosure components manufactured by molding or similar low cost methods.
Design for manufacturability & assembly, etc.

• Dimensioning and Tolerancing: Experience producing accurate and complete detail drawings using ASME Y14.5 GDT

AS Mechanical Design required; BS in Mechanical Engineering desired, or equivalent work experience

Supervisory Responsibilities:
This job has no supervisory responsibilities.

Required Training:
The area supervisor or department head (or delegate) shall determine what internal training (if any) is required in order to satisfactorily meet the job requirements listed above. Such training shall be conducted in accordance with applicable SOPs and said training shall be documented in accordance to our internal training procedure. The employee shall also receive general training in both 21CFR 820 and EN13485 as well as the OptiScan Quality Manual and Quality Policy.
This job description does not state nor imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job related duties as requested by management and will also be required to meet safety-related requirements. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.

If you are interested in applying to an open position at OptiScan, please email your resume to [email protected]