Jobs · Project Management · California

Senior Manager, Lifecycle Management

Edwards Lifesciences · Irvine, CA · 1 mo ago
Project Management$139k–$196k/yrFull-time
We need to output HTML fragment with sections: About the role? The posting includes description paragraphs. We need to use

for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections when posting has real specific content. We need to parse the posting. Content: - Intro: "Innovation starts from the heart..." description of company. Could be "About the role" or maybe "About the company". The instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we need to map content accordingly. We have: - Description of role: "The Senior Manager will lead the planning and execution of changes impacting Edwards' commercialized THV and/or TMTT product portfolios..." etc. That's responsibilities. - "How you'll make an impact:" bullet list of responsibilities. - "What you'll need (Required):" list of required qualifications. - "What else we look for (Preferred):" list of preferred qualifications/skills. - Benefits: "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." - Pay: "For California (CA), the base pay range for this position is $139,000 to $196,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience)." - Schedule: Not mentioned. So we should not include Schedule section. - Skills: Could be derived from preferred qualifications (Lean Six Sigma, etc.) but we already have Qualifications and Skills sections. The instruction says we can have Skills section separate. We need to decide what goes where. We have Required qualifications (Bachelor's degree, 10 years experience, etc.) and Preferred qualifications (Lean Six Sigma Belt certification, technical knowledge, etc.). Could map Required to "Requirements" and Preferred to "Qualifications" or "Skills". But we also have a separate "Skills" heading. Perhaps we put Required under "Requirements", Preferred under "Qualifications", and maybe skills under "Skills"? However the preferred list includes many skills and knowledge areas. Could treat them as Skills. We need to avoid filler like "commensurate with experience". Not present. We must not repeat job title as heading. Not include Job ID etc. We must remove boilerplate: EEO, equal opportunity, scam warning, etc. At end: "Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities." Remove that. Also remove "Applications will be accepted while this position is posted on our Careers website." That's application instruction; remove. Also remove "Aligning our overall business objectives..." we kept as Benefits. Now produce HTML: maybe not needed; just headings and content. We need

for each section heading. Inside each section, use

for prose,

  • for lists. We need to preserve all substantive information. Let's craft:

    About the role

    Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs.

    But is that about the role or company? Might be better as About the role? The role description is later. However we need to include something for About the role; we can use the introductory paragraph as about the role/company. It's substantive. Then Responsibilities: combine the paragraph after "The Senior Manager will lead..." and the "How you'll make an impact:" list. We need to keep all details. Let's extract responsibilities paragraph: "The Senior Manager will lead the planning and execution of changes impacting Edwards' commercialized THV and/or TMTT product portfolios. Serving as a key cross-functional leader, this role partners with Manufacturing, Supply Chain, Quality, Regulatory, and Engineering teams to assess risks, drive alignment, and ensure successful implementation of initiatives such as supplier changes, new market launches, manufacturing transfers, and other post-commercialization product updates. This position plays a critical role in maintaining business continuity, regulatory compliance, and uninterrupted supply to patients and customers worldwide." Then "How you'll make an impact:" followed by a series of statements separated by line breaks. We'll turn each into
  • . List items: - Manage large scale to enterprise-wide programs and initiatives (e.g., Product Focus Team (PFT), process equipment and automation programs) for ongoing global continuity of quality supply for commercial products as well as upstream during the product development process. - 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 objectives and activities. - Provide engineering expertise including business excellence methods (e.g. Six Sigma and LEAN) - Provide solutions to manufacturing issues 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, delivery systems, and electro-mechanical devices) and manufacturing intent from suppliers through distribution - Provide direction and guidance to project teams to execute tactical Supply Chain projects and/or initiatives - Ensure Manufacturing Readiness Reviews occur in advance of major builds following operations changes - Provide analyses, and track progress against agreed upon key business and operating metrics. - Provide input on executive summaries, and recommendations in support of new projects, initiatives, and/or programs to ensure adequate business continuity. - Escalate program risk to management when (e.g., LCM, process equipment implementation) projects are not executed successfully or do not deliver anticipated outcomes. - Ensure successful integration of process technologies or 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. - Ensure risks and mitigations are known to stakeholders and Senior Leadership. - Partner with Finance to quantify budget need to support programs and initiatives including project resources, expenses and capital expenditures to support project execution. We need to keep punctuation. Now Requirements (Required): "Bachelor's Degree in engineering, preferably Mechanical or Manufacturing Engineering with 10 years of related experience providing technical engineering support in medical device manufacturing and a demonstrated track record of successfully commercializing and sustaining medical devices Experience in Supply Chain such as Suppliers, Manufacturing, and/or Distribution Experience leading cross-functional teams without direct line reporting authority" We'll make each as
  • . Now Qualifications (Preferred) maybe we treat as Qualifications. Preferred list: "Lean Six Sigma Belt certification Technical knowledge and leadership in the area of 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, automation and equipment design and implementation, supplier development and process validation. Understand principles, theories, and concepts relevant to Engineering. Expert knowledge of Design Control for Class II & III medical devices Excellent problem-solving, analytical and critical thinking skills Proven expertise in both Microsoft Office Suite and manufacturing systems (e.g. PLM, Ignite) Excellent documentation and communication skills. Excellent ability to translate highly complex and technical information to all levels of the organizations including executive leaders. Extensive understanding of advanced processes and equipment used to manufacture medical devices Strict attention to detail Ability to manage competing priorities in a fast-paced environment Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control" We'll list each as
  • . Now Benefits: "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." We'll put as

    . Pay: "For California (CA), the base pay range for this position is $139,000 to $196,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience)." We'll put as

    . Schedule: not present, omit. Now ensure we don't include any boilerplate like EEO etc. Now produce HTML fragment. We need to wrap each section in maybe but not required. Just output headings and content. Let's craft:

    About the role

    Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs.

    Responsibilities

    The Senior Manager will lead the planning and execution of changes impacting Edwards' commercialized THV and/or TMTT product portfolios. Serving as a key cross-functional leader, this role partners with Manufacturing, Supply Chain, Quality, Regulatory, and Engineering teams to assess risks, drive alignment, and ensure successful implementation of initiatives such as supplier changes, new market launches, manufacturing transfers, and other post-commercialization product updates. This position plays a critical role in maintaining business continuity, regulatory compliance, and uninterrupted supply to patients and customers worldwide.

    • Manage large scale to enterprise-wide programs and initiatives (e.g., Product Focus Team (PFT), process equipment and automation programs) for ongoing global continuity of quality supply for commercial products as well as upstream during the product development process.
    • 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 objectives and activities.
    • Provide engineering expertise including business excellence methods (e.g. Six Sigma and LEAN)
    • Provide solutions to manufacturing issues 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, delivery systems, and electro-mechanical devices) and manufacturing intent from suppliers through distribution
    • Provide direction and guidance to project teams to execute tactical Supply Chain projects and/or initiatives
    • Ensure Manufacturing Readiness Reviews occur in advance of major builds following operations changes
    • Provide analyses, and track progress against agreed upon key business and operating metrics.
    • Provide input on executive summaries, and recommendations in support of new projects, initiatives, and/or programs to ensure adequate business continuity.
    • Escalate program risk to management when (e.g., LCM, process equipment implementation) projects are not executed successfully or do not deliver anticipated outcomes.
    • Ensure successful integration of process technologies or 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.
    • Ensure risks and mitigations are known to stakeholders and Senior Leadership.
    • Partner with Finance to quantify budget need to support programs and initiatives including project resources, expenses and capital expenditures to support project execution.

    Requirements

    • Bachelor's Degree in engineering, preferably Mechanical or Manufacturing Engineering with 10 years of related experience providing technical engineering support in medical device manufacturing and a demonstrated track record of successfully commercializing and sustaining medical devices
    • Experience in Supply Chain such as Suppliers, Manufacturing, and/or Distribution
    • Experience leading cross-functional teams without direct line reporting authority

    Qualifications

    • Lean Six Sigma Belt certification
    • Technical knowledge and leadership in the area of manufacturing

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