About Dexcom:
Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world.
Summary:
Under the direction of the Sr Manager, Operations Engineering , the Staff Mechanical Engineer provides technical leadership for the projects, functions, and strategic objectives of the Operations Equipment Group and department, concentrating on: engineering leadership for new product development; developing molding tools and the selection of components and equipment for molding based on analysis of specifications, reliability, and regulatory requirements.
Essential Duties and Responsibilities:
- Subject matter expert of injection molding, both large and small scale, including hot runner and cold runner tools as well as insert and over-molding.
- Conduct manufacturing capability and efficiency studies for molded products and inspection processes.
- Lead Design for Manufacturability (DFM) analysis for molded and over molded parts and Design for Inspection analysis for molded and over-molded part designs.
- Apply statistical methods to estimate future manufacturing requirements, production, and field performance data to identify issues and opportunities for improvements.
- Resolve complex process/product development and manufacturing issues.
- Ensure Design of Experiments (DOE) are appropriate to determine optimal processing methods.
- Facilitate in design control and take lead in developing, writing, and releasing manufacturing documentation.
- Fundamental understanding of materials including thermoplastics, thermosets, etc.
- Lead cross functional teams and suppliers on molding qualification activities for new processes, process changes, design changes, etc.
- Develop and maintain project timelines and provide updates and feedback to leadership. Coordinate with cross functional stakeholders and project PM on scheduling and engineering solutions.
- Plan, design, develop, execute, and lead production improvement projects including all necessary documentation.
- Plan, write, perform, and review validation IQ/OQ/PQ protocols and reports for all new or modified production equipment.
- This position assumes and performs other duties as assigned.
Additional duties would typically include:
- Actively participate in the development of injection molding and over-molding tool requirements, and end of arm tooling (EOAT) equipment.
- Lead in engagements with internal and external functions of the company for process development, process improvement projects, and alternate raw material and parts initiatives to improve product quality, decrease cost, and improve manufacturing efficiencies.
- Oversee internal resources and ensure communication to vendors on product specifications are accurate and arrange for purchase of equipment, materials and/or parts.
Essential Skills:
- Proven track record to run self-directed projects, maintain timelines, and execute in a fast-paced environment.
- General knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO)
- Familiarity with OSHA safety and ergonomics compliance
- Abilty to follow design, quality, and safety guidelines based on GMP, FDA, and ISO guidelines and related Quality and Safety Standards and Practices.Demonstrated ability to influence, motivate, and accomplish results through peers and junior level engineers
- Excellent communication (written and verbal) and personal interaction skills. Able to organize and prioritize assignments providing direction to and participation in assigned functional teams.
- Ability to apply engineering design and drafting tools, such as SolidWorks.
- Technical writing skills as applied to manufacturing documentation and process development – Experienced in the creation and revision of technical documentation.
- Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things.
- Key functional or cross functional liaison with stakeholders concerning operational or project deliverables.
Experience and Education Requirements:
- Typically requires a Bachelor’s degree in a technical discipline (Mechanical Engineering, Mechatronics Engineering, Bioengineering, or similar), and a minimum of 8-12 years related experience or Master’s degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience.
Travel Required: 0 – 25%
Preferred Qualifications:
- 1+ year(s) working in a regulated environment preferred.
- Medical device or regulated industry experience preferred.
- Lean six sigma certification preferred
Travel Required:
Functional Description: Technical Individual Contributors
Provides expertise in engineering, design, installation and start-up of automation systems. Actively assists manufacturing operations in problem solving with regards to the automated systems. Assists in the validation of process and facility automation. May also develop code and design system architectures in order to define user compatibility.
Functional/Business Knowledge:
- Possesses advanced knowledge of technical principles and theories. Recommends solutions in support of functional objectives tied to overall company objectives and strategies.
Scope:
- Demonstrates significant technical expertise, collaboration with others and independent thought. Anticipates potential complex problems requiring an in‐depth evaluation. Demonstrates strategic thinking and commercial/industry understanding in functional projects.
Judgement:
- Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
- Determines methods and procedures on new assignments and may coordinate activities of other colleagues.
Language Skills: Must be able to communicate effectively in English. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May be required to perform the following Physical Activity: Standing, walking, sitting, using hands, handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl, talk or hear, taste or smell. May be required to lift 0 lbs. to over 50 lbs.
Work Environment: The work environment characteristics described here 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. May be exposed to the following environmental conditions: Wet or humid conditions, work near moving parts, work in high – precarious places, fumes or airborne particles, toxic or caustic chemicals, outdoor weather conditions, extreme heat (non-weather), extreme cold (non-weather), risk of electric shock, work with explosives, risk of radiation, vibration. The noise level in this work environment can range from quiet to very loud.
Workplace Type: The Workplace Type for this role is Flex. Based on the nature of your position you will be working onsite approximately 2-3 days per week from collaborative space and hoteling desks at our Dexcom sites. You will need to be located within commuting distance (typically 75 miles/120km) of your assigned Dexcom site.
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons.
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If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at [email protected].
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at [email protected].
View the OFCCP’s Pay Transparency Non Discrimination Provision at this link.
Source: Indeed.com
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