Staff Technologist - Maintenance/Manufacturing Support Engineer
About the job
- A high school diploma or equivalent and 15 years of related experience, or an associate's degree or equivalent and 13 years of related experience.
- Strong written and verbal communication, interpersonal, and relationship-building skills, including creating presentations, influencing others, and conveying recommendations.
- Knowledge of problem-solving methodology, root cause analysis, and Good Documentation Practices.
- Strong computer skills, including Microsoft Office Suite; computer-aided design skills if applicable.
- Extensive knowledge of validation and improvement of automated equipment.
- Ability to troubleshoot manufacturing equipment.
- Knowledge of material compatibility in the proposed use environment.
- Ability to execute the fundamentals of project management.
- Extensive knowledge of routine preventive maintenance of production equipment.
- Extensive knowledge of electrical, mechanical, electronic, pneumatic, and controls disciplines.
- Knowledge of and adherence to company Environmental Health and Safety and Quality guidelines as they relate to clean-room medical-device manufacturing.
- Knowledge of Good Manufacturing Practices and Good Documentation Practices in a medical-device environment.
- Ability to work independently on complex projects, develop work instructions, and guide technicians to advance their competency.
- Adherence to company rules and requirements, including pandemic protocols and Environmental Health and Safety rules, and taking adequate control measures to prevent injuries and pollution.
- Provide technical manufacturing support to Operations and Engineering.
- Serve as a key subject matter expert with in-depth knowledge and technical proficiency in asset management, equipment maintenance, and manufacturing support activities.
- Design, set up, and execute complex feasibility studies, experiments, and tests using established or newly created protocols; develop findings for equipment and manufacturing-process validation and improvement based on engineering principles; analyze results, make recommendations, and develop reports for Engineering review.
- Manage all aspects of projects using tools such as Microsoft Project and Gantt charts to ensure on-time and on-budget completion, including interfacing with parties, allocating resources, negotiating competing priorities, mediating conflicting objectives, and escalating issues for resolution.
- Collaborate with Engineering on systemic root-cause investigations for corrective and preventive action.
- Review documentation and take appropriate actions to ensure it is catalogued; follow through on equipment validation and qualification, including transferring information to appropriate locations such as engineering change requests, standard operating procedures, drawings, and tooling for Engineering approval.
- Lead projects to develop new complex tools and equipment for implementation in multiple areas.
- Design, develop, and sustain processes and procedures, including methods to train users.
- Use manufacturing software such as JDE, QMS, and PLM to update documentation in systems such as engineering change requests and Blue Mountain.
- Provide coaching and guidance to technicians.
- Arrive on time, maintain regular attendance without excessive absenteeism, and work a full eight-hour or longer work period.
- Perform other incidental duties, such as occasional photocopying or deliveries.
- Fifteen years of previous experience in manufacturing and/or medical-device experience is preferred.
About the company
Edwards Lifesciences focuses on cardiovascular medical technologies, especially transcatheter heart valves. Its products enable repairing or replacing diseased heart valves through minimally invasive procedures rather than open-heart surgery. The company builds on a long history that began with the Starr-Edwards valve and now centers on valve therapies and related diagnostics to treat heart disease. It differentiates itself by specializing in valve technologies and transcatheter approaches, backed by a track record of clinical leadership and global reach. The goal is to improve patient outcomes by providing safer, less invasive valve treatment options for people around the world.
Company Size
10,001+
Company Stage
IPO
Headquarters
Irvine, California
Founded
1958
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Simplify's Take
What believers are saying
- CMS finalized expanded TAVR coverage September 10, 2026, enlarging addressable Medicare volume.
- Q2 2026 sales rose 13.6% to $1.74 billion; management raised full-year guidance.
- AUTUS approval and ECLIPTIS launch broaden growth beyond mature TAVR programs.
What critics are saying
- FTC settled July 2026 JC Medical charges for $10 million and compliance oversight.
- January 2026 injunction blocked JenaValve buyout, crippling Edwards' aortic-regurgitation acquisition strategy.
- AtriaCure, Medtronic, and Boston Scientific attack Edwards' adjacencies; failure here destroys diversification.
What makes Edwards Lifesciences unique
- Edwards owns SAPIEN TAVR leadership and the 2025 asymptomatic-label exclusivity.
- AUTUS, approved October 1, 2026, creates a pediatric pulmonary-valve franchise.
- ECLIPTIS, cleared July 2026, extends Edwards into surgical stroke-prevention during cardiac surgery.
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10%Edwards Lifesciences (EW) receives a Buy from RBC Capital. Oct. 2, 2026, 09:46 PM RBC Capital analyst Kendall Au maintained a Buy rating on Edwards Lifesciences on October 1 and set a price target of $110.00. The company's shares closed yesterday at $85.19. Au covers the Healthcare sector, focusing on stocks such as Becton Dickinson, GE Healthcare Technologies Inc, and Boston Scientific. According to TipRanks, Au has an average return of -3.6% and a 22.22% success rate on recommended stocks. The word on The Street in general, suggests a Strong Buy analyst consensus rating for Edwards Lifesciences with a $103.40 average price target, representing a 21.38% upside. In a report released on September 28, Leerink Partners also reiterated a Buy rating on the stock with a $101.00 price target. Based on Edwards Lifesciences' latest earnings release for the quarter ending June 30, the company reported a quarterly revenue of $1.74 billion and a net profit of $241.9 million. In comparison, last year the company earned a revenue of $1.53 billion and had a net profit of $329.8 million Based on the recent corporate insider activity of 110 insiders, corporate insider sentiment is negative on the stock. This means that over the past quarter there has been an increase of insiders selling their shares of EW in relation to earlier this year. Most recently, in August 2026, Annette Bruls, the CVP, EMEACLA of EW sold 2,644.00 shares for a total of $237,907.12. Read More on EW:
Edwards Lifesciences has received FDA approval for the AUTUS Size-Adjustable Valve, the first surgical pulmonary valve designed specifically for paediatric patients with congenital heart disease. The valve can be expanded as a child grows through a minimally invasive transcatheter procedure, potentially reducing the need for repeat open-heart surgeries. The approval was based on a pivotal study that met its primary safety and effectiveness endpoints. All patients were free from device-related complications through 30 days, with no valve reinterventions through six months. Patients who completed one-year follow-up showed consistent outcomes with favourable valve performance. The AUTUS valve previously received FDA Breakthrough Device designation for addressing an important unmet need in paediatric cardiac care.
Edwards Lifesciences, an Irvine, California-based cardiovascular products company, has underperformed the Dow Jones Industrial Average in recent months. The stock is down 6.6% from its 52-week high of $96.29 reached on 7 July. Over the past three months, Edwards Lifesciences shares grew 2.8%, lagging the Dow's 3.5% gain. The 52-week performance shows similar underperformance, with the stock up 11.4% compared to the Dow's 17.1% increase. Despite this, the company reported strong Q2 results on 23 July, with net sales rising 13.6% year-over-year to $1.7 billion. Adjusted earnings per share of $0.78 beat Wall Street estimates. The company raised its 2026 sales growth guidance to 10-11% from 9-11% previously. Analysts maintain a "strong buy" consensus rating, with a mean price target suggesting 13.5% upside potential.
Edwards Lifesciences to present at the Deutsche Bank Healthcare Summit. Key Takeaway: Edwards Lifesciences Corporation will present at the Deutsche Bank Healthcare Summit on September 16, 2026. CEO Bernard Zovighian and CFO Doretta Mistras will represent the company. A live webcast of the presentation will be available on their investor relations website. Market sentiment analysis. Positive factors. * Edwards Lifesciences is actively engaging with investors. * Participation in a prominent healthcare summit highlights company visibility. * CEO and CFO are presenting, indicating strong leadership presence. IRVINE, Calif.-(BUSINESS WIRE)-Edwards Lifesciences Corporation (NYSE: EW) will participate in the Deutsche Bank Healthcare Summit on Wednesday, Sept. 16, 2026.Bernard Zovighian, chief executive officer, is scheduled to present at 10:00 a.m. ET. Doretta Mistras, chief financial officer, will also participate in the conference. A live webcast of the presentation will be available on the Edwards Lifesciences investor relations website at http://ir.edwards.com/, with an archived version accessibl Frequently asked questions. When will Edwards Lifesciences present at the summit? Edwards Lifesciences will present on September 16, 2026. Who will represent Edwards Lifesciences at the summit? CEO Bernard Zovighian and CFO Doretta Mistras will represent the company. Is there a webcast available for the presentation? Yes, a live webcast will be available on their investor relations website.
Antitrust: KKR agrees to record settlement of HSR non-compliance claims. August 31, 2026 Last year, DealLawyers blogged about the DOJ's decision to file a lawsuit against KKR, in which it alleged that the buyout giant engaged in multiple failures to comply with the HSR Act's pre-merger notification requirements. Last week, the parties filed a proposed settlement of that lawsuit with the SDNY. This excerpt from a White & Case memo summarizes the terms of the settlement: On Wednesday, August 26, 2026, the DOJ filed a proposed settlement requiring KKR & Co. Inc. to pay a civil penalty of $250 million, more than 20 times any prior HSR penalty obtained by the DOJ. Associate Attorney General Stanley Woodward indicated that this proposed settlement "sends a powerful message" and shows that the DOJ "is committed to vigorous enforcement of the Act." This settlement comes after the DOJ alleged in January 2025 that the private equity sponsor "repeatedly violated the HSR Act" through "systemic" violations. Key allegations in the DOJ's complaint included: - Failure to submit responsive business documents required under Item 4 of the HSR Form - Altering or removing content and pages in final Item 4 documents before submission to the FTC/DOJ as part of required HSR filings - Failure to make HSR filings before consummating reportable transactions The memo quotes a KKR spokesperson as saying that the organization determined that continuing the litigation would be a distraction to the organization & that KKR was pleased to put the litigation behind it. They also noted that their investors wouldn't feel the bite, because KKR "will be fully reimbursed by outside law firms." Yikes!!! The settlement comes on the heels of last month's settlement of the FTC's actions targeting Edwards Lifesciences & Genesis Medtech's for alleged violations of the HSR Act. At the time, the $12 million fine that the companies agreed to pay was the largest ever for failing to make an HSR filing. I guess records were made to be broken. - John Jenkins