Sr. Manufacturing Engineer

Lighteum Medical, a Medical Device Components LLC; San Diego (CA); On-site; USD 115,000 - 125,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) with company match

PTO, sick leave, and holidays

Job summary

Lighteum Medical, a Medical Device Components LLC, is seeking a Sr. Manufacturing Engineer in San Diego, CA. The role focuses on providing technical support to production, leading site improvement projects, and ensuring compliant manufacturing processes.

The ideal candidate has 5+ years in manufacturing, experience in the medical device sector, and strong Lean/Six Sigma, CAD/CAM, and data analysis skills. Travel up to 5% may be required.

Qualifications

• Minimum 5 years’ experience in a manufacturing environment.
• Experience in the medical device industry.
• Working knowledge in Lean Manufacturing and Six Sigma.
• Proficient in CAD/CAM tools and statistical software.

Responsibilities

• Provide technical support to production departments and lead site improvement and expansion projects.
• Design and improve tooling and equipment used in production and validate with industry techniques.
• Support transfer of new technologies from Development to Production with the NPI group.
• Lead area development and manage site metrics on the site scorecard.
• Apply Lean principles to drive process improvements and Kaizen initiatives.

Skills

Lean Manufacturing

Six Sigma

Data analysis

Power BI

CAD/CAM

Solidworks

MasterCam

Esprit

Office 365

Equipment operation

Tools

Solidworks

MasterCam

Esprit

Job description

Sr. Manufacturing Engineer

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Full Time, San Diego, CA, US

Salary Range: $115,000.00 - $125,000.00 Annually

We offer a comprehensive benefits package designed to support our associates’ well‑being. Our health and wellness benefits feature comprehensive medical, dental, and vision insurance. To promote financial security, we also provide a 401(k) plan with generous company contribution and match, flexible spending accounts, and life and disability insurance. Our paid time off policy is generous, including PTO, sick leave, and paid holidays.

Job Purpose: This position is responsible for providing technical support to various production departments and leading critical site improvement and expansion projects. The role requires the engineer to build a deep understanding of Lighteum’s operation which includes technical aspects of the processes, the Voice of the Customer reflected on the quality requirements and the Voice of the Business. The engineer will combine that knowledge to make sound decisions that improve our processes.

Principal Accountabilities

• Provide technical support to help manage change and troubleshoot problems. Support with coaching other engineers on problem solving and project management.
• Design and improve existing tooling and equipment used in production and validate such equipment using standard medical device industry techniques.
• Work in collaboration with the NPI engineering group to support the transfer of new technologies and products from Development to Production.
• Lead the development, improvement, and strategy of the area(s) in which incumbent is accountable for. Own key site metrics related to accountable areas on site scorecard.
• May oversee and lead work of other Engineers.
• Applies Lean principles to drive process improvements across various departments and supports ongoing Kaizen/Process improvement projects.
• Develops capital equipment justifications for new machines or processes technologies that will support site goals of increasing quality, cost, and/or cycle time.
• Manages capital equipment projects, including budgetary responsibilities, equipment validation (IQ/OQ/PQ), and effective transfer to production.
• Understands the Quality Policy and Quality Objectives, follows applicable Quality Operating Procedures and Quality Management System requirements, and complies with ISO standards relevant to the position.
• Participates in local programs and initiatives to sustain and improve EHS performance.
• Identifies and validates appropriate metrology tools and inspection methods to verify product conformance in accordance with Measurement System Analysis (MSA) requirements.
• Characterizes, optimizes and validates equipment and processes based on statistical experimentation.
• May travel 5% of the time based on projects assigned.

Scope

The Sr Manufacturing Engineer reports to the Site Director and will regularly interact with all other departments on site. Will frequently work with New Production Introduction, Operations, Quality and Supply Chain to support ongoing site objectives. Incumbent will design and possibly manufacture specialized production equipment and mistake‑proofing tools as the need arises or when no commercial options are available.

Personnel Specification

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. The physical requirements and work environment described are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Qualifications / Knowledge / Experience

• Minimum 5 years’ experience in a manufacturing environment
• Experience in the medical device industry.
• Working knowledge in Lean Manufacturing and Six Sigma.
• Ability to operate manufacturing related machinery such as: bench grinder, mill, lathe, laser
• Proficient in Office 365 and other software to support his/her work.
• Proficient in Minitab or other statistical software.
• Proficient in data analysis and presentation (Power BI preferred).
• Proficient in CAD/CAM (Solidworks, MasterCam, & Esprit preferred)
• Ability to occasionally lift 10-20 pounds

Personal Skills and Key Competencies

• Continuous Improvement: Originating action to improve existing conditions and processes; identifying improvement opportunities, generating ideas, and implementing solutions.
• Planning & Organizing: Establishing courses of action for self and others to ensure that work is completed efficiently.
• Initiating Action: Taking prompt action to accomplish objectives; taking action to achieve goals beyond what is required; being proactive.
• Communication: Clearly conveying information and ideas through a variety of media to individuals or groups in a manner that engages and helps them understand and retain the message.
• Safety Awareness: Identifying and correcting conditions that affect employee safety; upholding safety standards.