Easter Seals Jobs

Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.

The Director will develop and ensure project management and deliver product design expertise to address new markets, continuous and quality improvements, regulatory changes, efficiencies across the Implant Network, production transfers, phase-out(s), synergies with the businesses, and unplanned events or disruptions while serving as core Leader of Product Focus Teams (PFT) with the business objectives to maintain a leading position in the medical device market across surgical and trans-catheter businesses.

How you’ll make an impact:

• Manage strategic to enterprise-wide Product Focus Team (PFT) projects for ongoing global continuity of quality supply for both legacy and launched commercial products. Ensure appropriate Global Supply Chain (GSC) integration into product lifecycle management through collaboration with R&D, Marketing, Quality, and Regulatory Affairs, and downstream with the manufacturing and other critical GSC functions to ensure alignment of PFT project plan objectives and activities. Provide engineering expertise including business excellence methods (e.g. Six Sigma and LEAN), lead the facilitation of the overall project strategy and implement some changes as appropriate.

• Provide innovative solutions to complex manufacturing issues in specialized areas, internal or external, to ensure adequate business continuity and to guarantee the highest level of quality and service to customers to safeguard the medical product design (materials, tissues, and delivery systems,) and manufacturing intent from suppliers through distribution.

• Provide direction and guidance to project teams to execute larger Supply Chain projects and/or initiatives.

• Ensure successful transfer of stabilized products into and between Edwards Commercial Manufacturing facilities and External Manufacturers by working closely with the business partners from those areas. Continue to drive product launches into additional markets. Make sure risks and mitigations are known to stakeholders and Senior Leadership. Define and facilitate the synergies with the Business Unites (BUs) and the manufacturing sites.

• Establish, provide analyses, and track progress against agreed upon key business and operating metrics. Develop executive summaries, and recommendations to facilitate strategic decision making and gain buy-in from Senior Management in support of new projects, initiatives, and/or programs to ensure adequate business continuity. Escalation of program risk to management when LCM projects are not executed successfully or do not deliver anticipated outcomes.

• Partner with Finance to anticipate and quantify budget need to support LCM projects including project resources, expenses, and capital expenditures to support project execution. Provide Operations input and assumptions into the financial business case for LCM projects with plan to maintain or improve gross profit targets.

• Review and approval of Product Lifecycle Management documentation updates such as impact assessment, project charters, design control documents, audit responses.

• Travel 25% domestically and globally.

What you’ll need:

• Bachelor’s degree in engineering, preferably Mechanical, or Manufacturing Engineering.

• 12 years of experience in providing technical engineering support in medical device manufacturing of and a demonstrated track record successfully commercializing and sustaining medical devices throughout the end-to-end supply chain.

• Experience in multiple areas of Supply Chain such as Suppliers, Manufacturing, and/or Distribution.

What else we look for:

• Strong Technical knowledge and leadership in manufacturing engineering of medical devices including process excellence methodologies such as Six Sigma, cGMP, DFM, LEAN, EH&S guidelines, FDA guidelines ISO standards, ergonomics, GD&T, supplier development and process validation. Understand principles, theories, and concepts relevant to Engineering.

• Expert in knowledge of Design Control for Class II & III medical devices, including familiarity with one or more of the following: device sterilization, implants, and mechanical devices

• Expert understanding of advanced processes and equipment used to manufacture medical devices.

• Strong leadership and influencing skills with the ability to build global strategic partnerships across the organization, including executive leadership team.

• Experience leading cross-functional teams without direct line reporting authority.

• Proven successful project management skills, including the development and management of dashboard.

• Proven expertise in both Microsoft Office Suite and manufacturing systems (e.g. PLM).

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $156,000 to $221,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.