Description

Manufacturing Engineer

How would you like to work for an innovative, forward-thinking company that manufactures and distributes high quality healthcare products for the world? If you are passionate about teamwork, are driven by exceeding expectations in all that you do and thrive in an organization that promotes having fun while making a difference, join us!

As a privately held company since 1991, we at BioFilm, research, develop, and manufacture the best healthcare products to enhance intimate activities, quality of life and protective wellness. In beautiful Vista, California, our facility is the hub!

You’ll work with leading researchers, engineers and scientists in a culture that embraces ingenuity.

What we offer:

4-day work weeks – every Monday off!

Health, dental, and vision insurance (with employee contribution) plus Health Reimbursement Account and Flexible Spending Account options available

Matching 401K and profit-sharing

Discretionary annual bonuses based on profits

Generous PTO and holiday schedule including paid time off from Christmas Eve to New Year's Day

Alternative Work Week: BioFilm works an alternative work schedule of four 9.5-hour days. You will be likely assigned to one of the following schedules, 6:00 am – 4:30 pm -or- 7:00 am – 5:30 pm, with one hour for lunch.

Manufacturing Engineer...

Purpose of Position

The Manufacturing Engineer is responsible for the design, maintenance and improvement of all process-related activities. Implement process control and continuous process improvements to meet manufacturing objectives. Work closely with cross-functional teams and focus on identifying opportunities and solutions to improve quality, throughput and overall manufacturing efficiency.

5 Key Roles of Accountability

Manufacturing process improvements

Research, Design ROI calculation, & installation of new equipment, tooling and fixtures

Validation of new and existing equipment, processes and products.

Writing and improving Manufacturing Instructions and Standard Operating Procedures.

Create and maintain product BOMs, Routings and Quality Inspection Specifications.

Essential Duties And Responsibilities

Develops, documents and optimizes manufacturing processes and operating procedures within a regulated quality system utilizing lean manufacturing principles.

Ensures all projects/processes are in compliance with FDA, Current Good Manufacturing Practices (cGMP), Quality System Requirement (QSR), ISO-13485 and other applicable requirements.

Designs, writes, reviews, and approves validations, IQ/OQ/PQ protocols, technical reports, and final reports for new products, processes, and equipment.

Writes, maintains, reviews, and improves Standard Operating Procedures (SOP’s), MI’s, & SI’s.

Providing input and approvals for deviations & NCMR’s

Create and maintain product Bills of Materials, Production Routings, and quality specifications.

Assist in design, testing, and validation of packaging for new products or product improvements.

Interacts with product design and development personnel to ensure that processes and designs are compatible with manufacturing capabilities to ensure proper scale ups can occur.

Troubleshoot production line issues, address yield and quality issues and drive implementation of solutions to meet production goals by utilizing various methods such as constructing and executing controlled experiments including DOEs, etc.

Assists in identification and implementation of advanced manufacturing technologies and makes recommendations for process requirements of new or existing product lines.

Assists in the review and evaluation of capacity models and anticipates when new equipment or additional headcount will be required; performs Return on Investment (ROI) analysis.

Evaluates technical problems and drives down to root causes in order to implement sustainable resolutions.

Trains manufacturing personnel.

Responsible for working in compliance with Quality System Regulations (QSR), safety and all other applicable company policies.

Responsible for maintaining a clean and safe work environment by identifying all safety hazards and recommending corrective actions when necessary.

Takes a proactive approach to continuous improvement initiatives by analyzing existing processes and applying lean manufacturing techniques and concepts in order to improve production efficiencies, throughput and quality.

SUPERVISION RECEIVED:

Works under general direction of the Engineering Supervisor

Requirements

Qualifications and Education Requirements:

• BS Degree in Mechanical, Electrical or Industrial Engineering or equivalent manufacturing experience in process improvement, equipment design, troubleshooting, maintenance & repairs.
• Minimum 2 years (5 years preferred) of experience in an engineering function dealing with processes and equipment in a medical device manufacturing environment.
• Or with the absence of a degree Minimum 10 years of experience in an engineering function dealing with processes and equipment in a cGMP/FDA/ISO manufacturing environment.
• Lean/Six Sigma certification preferred
• Project Management experience preferred
• Strong technical skills and ability to learn and work with electrical and mechanical systems including PLCs, vision systems, robotics and other automated equipment.
• Proven technical writing experience including process documentation, IQ/OQ/PQ protocols and reporting.
• Experience with batch mixing, bottle filling and packaging equipment preferred.
• Solid modeling and drafting – Solidworks, AutoCAD
• Previous experience in the areas of Design for Manufacturing DFM, Design of Experiments DOE and product/process Failure Mode and Effects Analysis FMEA

LANGUAGE SKILLS:

• Ability to read, write and speak fluent English.

JUDGMENT/REASONING ABILITY:

• Able to recognize and resolve problems quickly using sound judgment and diplomacy.

OTHER SKILLS AND ABILITIES:

General Skills

Detail oriented.

Analytical abilities.

Good organizational skills.

Ability to work as part of a team.

Must be self-motivated with ability to use own initiative.

Flexibility to change direction frequently and with little notice.

Able to handle multiple tasks simultaneously.

Excellent planning and organization abilities.

Able to complete projects under tight deadlines, even when there are competing requirements and changes in assignments.

Legible Handwriting

Office Skills

Computer literate in a Windows Environment; Excel, OneNote, Teams, , Word, PowerPoint, .

ERP software experience including Microsoft Dynamics NAV or similar.

Quality software experience including QCBD, Master Control or similar

Math Skills

Basic Statistical skills.

Accurate counting skills.

Communication Skills

Legible handwriting.

Detail Oriented

Strong written and verbal communication skills.

Strong interpersonal skills with the ability to use tact and diplomacy.

Excellent communication and negotiation skills.

Strong training skills

PHYSICAL DEMANDS:

Ability to lift up to 30 pounds.

Good visual color perception.

Able to stand, stoop, bend, Climb Ladders, and access applicable equipment

Ability to walk and stand on cement floors for long periods.

Able to sit at desk and use/view computer for prolonged periods of time, up to 10 hours daily.

WORK ENVIRONMENT:

Fast paced with multi-level distractions.

Non-smoking.

Professional, yet casual work environment.

Office environment.

SPECIAL CONDITIONS:

Ability to work extended hours as needed.

Ability to Travel as Needed