Mechanical Engineering P18

Position Summary

The Staff Mechanical Engineer shall produce specifications for design develop verify and validate new or modified mechanical components or systems in medical-grade sterilization capital accessories and consumables.

Duties and Responsibilities

Under limited supervision general direction etc. and in accordance with all applicable government laws regulations and ASP policies procedures and guidelines this position:

• Deliver and drive results by participating in new product development projects either as a team member or work stream leader focused on mechanical centric design and development
• Connects by demonstrating strong collaboration with cross functional team members to ensure alignment and influencing of design concepts design inputs design outputs and design verification.
• Provides strong technical leadership on assigned projects to deliver design concepts design characterization design inputs design outputs and design verification using sound engineering principles and expertise.
• Provides guidance and mentorship to junior engineers draftsmen technicians and contractors.
• Responsible for communicating business related issues or opportunities to next management level
• Performs other duties assigned as needed

Other Duties:

N/A

• Assess project requirements
• Measure the performance of mechanical components devices and systems
• Align budgets timescales and specifications with cross-functional stakeholders customers and management
• Use computer-aided design FEA and CFD software
• Undertake relevant research
• Produce and Implement designs and test procedures with compliant GDP
• Present designs drive technical reviews and own work streams
• Write protocols reports and other QMS documentation
• Providing technical support to cross-functional teams
• Analyze and interpret data.

Education:

High School or Equivalent

Associate degree

Bachelors Degree Mechanical Engineering

Masters Degree

PhD Degree

Years of Related Experience:

List specific types of experience and years that may be required for this position such as:

• 8 year of related experience in new product development required; highly regulated industry experience preferred (e.g. Aerospace Automotive Medical Devices)
• 6 years minimum of CAD design experience required; SolidWorks preferred

Knowledge Skills Abilities Certifications/Licenses and Affiliations:

(Include any required computer skills regulatory knowledge certifications licenses languages cognitive and behavioral abilities etc.)

• Thorough understanding of Design Verification and Validation highly preferred
• Strong written and verbal communication required
• Design experience for plastics highly preferred
• GD&T working knowledge highly preferred
• Medical device product development experience highly preferred
• Fluidic Systems experience a plus
• Sterilization and/or disinfection experience a plus

• This position does not entail direct supervisory responsibilities.
• Internal interface activities will include but not limited to Quality Operations Regulatory Compliance Marketing Medical Safety Field Services and Medical Safety.

• Liaise with suppliers development partners and manufacturers to support new product development sustaining engineering and manufacturing.

Scheduled Work Hours

Shift Work

ASP Logistic Center

Field Based

Work Remotely

Irvine

Schaffhausen

Zug

Other: Enter N/A if not selected.

Standing: 10-20%

Kneeling: 0-10%

Sitting: Up to 80%

Walking: 10-20%

All managers and employees shall proactively support ASPs Environmental Health and Safety (EHS) Policy by providing the necessary resources and giving equal emphasis with other functions such as production and quality. It is the duty of every manager and employee to:

Ensure implementation of safety and environmental procedures guidelines and standards.

Evaluate employee compliance and enforce established safety and environmental procedures and rules.

Create a safe work area environment recognize safe activities and reward good safety performance.

Provide training to employees when:

• Hired
• Transferred
• New substances processes procedures or equipment are introduced to the workplace and represent a new hazard

Measure safety performance and hold persons accountable for activities and results.

Ensure that incidents are investigated to determine root cause and that corrective actions are taken.

Ensure employees wear required protective equipment.

Ensure EHS inspections are conducted monthly and corrective actions are implemented.

Machine Operation

Electrical Hazards

Laser Hazards

Excessive Noise (>85 dB)

Heights (> 6ft)

Hazardous Chemicals/Fumes

Excessive Dust

Bloodborne Pathogen

Biohazards(BBP and parts of LAH)

Extreme Heat/Cold

N/A

Forklift

Motorized Pallet Jack

Lifting Requirement

N/A

Choose an item.

Ground to knees

Ground to Waist

Ground to Shoulders

Ground to Overhead

Waist to Shoulders

Waist to Overhead

Twisting Motion

Computer Entry

Simple Grasp

Fine Manipulation

All employees have a duty to comply with applicable laws regulations standards ASP policies and procedures.

This job description is intended to convey information essential to understanding the scope of this position and it is not intended to be an exhaustive list of skills efforts duties responsibilities or working conditions associated with the position.Employees are required to follow any other job-related instructions and perform job-related duties as may be reasonably assigned by his/her supervisor. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential duties of the job.

This section shall be used for local Government Regulations or Laws which require the job description to be signed by the employee and manager. A scanned copy of the signed document is uploaded into the Learning Management System.