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Senior Process Development Engineer

Sword Health is on a mission to free two billion people from pain as the world’s first and only end-to-end platform to predict, prevent and treat pain. 


With 67% of members achieving a pain-free life and a 70% reduction in surgery intent, at Sword, we are using technology to save millions for our 25,000 enterprise clients across three continents. Today, we hold the majority of industry patents, win 70% of competitive evaluations, and have raised more than $300 million from top venture firms like Founders Fund, Sapphire Ventures, General Catalyst, and Khosla Ventures.


Recognized as a Forbes Best Startup Employer in 2024, this award highlights our focus on being a destination for the best and brightest  talent. Not only have we experienced unprecedented growth since our market debut in 2020,  but we’ve also created a remarkable mission and value-driven environment that is loved by our growing team. With a recent valuation of $3 billion, we are in a phase of hyper growth and expansion, and we’re looking for individuals with passion, commitment, and energy to help us scale our impact. 


Joining Sword Health means committing to a set of core values, chief amongst them to “do it for the patients” every day, and to always “deliver more than expected” on behalf of our members and clients.


This is an opportunity for you to make a significant difference on a massive scale as you work alongside 900+ (and growing!) talented colleagues, spanning three continents. Your charge? To help us build a pain-free world, powered by technology, enhanced by people — accessible to all.


The Process Development Engineering Manager role is responsible for leading the team supporting development, qualification, maintenance, and continuous improvement of global manufacturing operations for Sword Health.


What you will be doing:
  • Oversee a remote team of process development engineers and technicians in Salt Lake City (USA) and Canelas (Portugal);
  • Maintain manufacturing oversight of overseas manufacturing operations in SE Asia;
  • Design, develop, optimize, and scale up manufacturing processes for new and existing products;
  • Maintain and refine SPC manufacturing metrics;
  • Oversee maintenance on Sword-controlled Production Assets (scheduled and unscheduled);
  • Support engineering teams to define, develop, and launch production lines in support of existing and new products;
  • Work with Production & Quality teams on develop and maintain process documentation, such as standard operating procedures, work instructions, and process flow diagrams;
  • Conduct Installation, Operational, and Performance Qualifications (IQ/OQ/PQ);
  • Development and execution of protocols and filling out reports;
  • Ensure compliance with regulatory requirements, including FDA, ISO etc. Periodically supports periodic facility and workforce compliance audits.


What you need to have:
  • Degree in Mechanical, Manufacturing, or Industrial Engineering or related field;
  • 8+ years of experience in manufacturing or industrial engineering for medical devices or within a regulated industry;
  • Prior experience managing a remote team;
  • Highly independent and self-directed;
  • Ability to work with our remote teams in SLC, NY, and Porto;
  • Excellent verbal and written communication skills;
  • Excellent organizational skills and attention to detail;
  • Time management skills with a proven ability to meet deadlines;
  • Strong analytical and problem-solving skills, including Statistical Analysis of data;
  • Ability to prioritize tasks and to delegate them when appropriate;
  • Ability to function well in a high-paced and at times stressful environment;
  • Proficient in English and Spanish (to easily converse with production specialists and operators).


To ensure you feel good solving a big Human problem, we offer:
  • A stimulating, fast-paced environment with lots of room for creativity;
  • A bright future at a promising high-tech startup company;
  • Career development and growth, with a competitive salary;
  • The opportunity to work with a talented team and to add real value to an innovative solution with the potential to change the future of healthcare;
  • A stimulating environment with room for creativity;
  • A flexible environment where you can control your hours (remotely) with unlimited vacation;
  • Access to our health and well-being program (digital therapist sessions);
  • Remote or Hybrid work policy.


*Please note that this position does not offer relocation assistance. Candidates must possess a valid EU visa and be based in Portugal.



US - Sword Benefits & Perks:


• Comprehensive health, dental and vision insurance*

• Equity shares*

• Discretionary PTO plan*

• Parental leave*

• 401(k)

• Flexible working hours

• Remote-first company

• Paid company holidays

• Free digital therapist for you and your family

*Eligibility: Full-time employees regularly working 25+ hours per week


*US Applicants Only: Applicants must have a legal right to work in the United States, and immigration or work visa sponsorship will not be provided.



SWORD Health, which includes SWORD Health, Inc. and Sword Health Professionals (consisting of Sword Health Care Providers, P.A., SWORD Health Care Providers of NJ, P.C., SWORD Health Care Physical Therapy Providers of CA, P.C.*) complies with applicable Federal and State civil rights laws and does not discriminate on the basis of Age, Ancestry, Color, Citizenship, Gender, Gender expression, Gender identity, Gender information, Marital status, Medical condition, National origin, Physical or mental disability, Pregnancy, Race, Religion, Caste, Sexual orientation, and Veteran status.

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CEO of Sword Health
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Virgilio Bento
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What You Should Know About Senior Process Development Engineer, Sword Health

Are you ready to take your engineering career to the next level? At Sword Health, we believe in transforming lives and improving healthcare, and we need a passionate and skilled Senior Process Development Engineer to join our team in beautiful Porto. As an esteemed leader at Sword Health, your main mission will be leading a remote team of process development engineers and technicians located in Salt Lake City and Canelas. You’ll oversee the manufacturing operations, ensuring everything runs smoothly while maintaining high standards of quality and efficiency. Your expertise in designing and optimizing manufacturing processes will play a vital role in bringing our innovative medical devices to life. Imagine working in an environment where technology meets heart, impacting the lives of two billion people worldwide! You’ll have the opportunity to develop new products, refine process documentation, and ensure compliance with necessary regulations. We’re a fast-paced, dynamic team that values creativity and dedication, offering a stimulating workplace where you will continually grow your skills. Our commitment to creating a pain-free world is strong! Here’s your chance to contribute to an exciting vision that marries engineering excellence with compassion and care. Join us if you’re ready to challenge the status quo and make a real difference together with over 900 talented colleagues on three continents. Let’s build a brighter future for healthcare, one process at a time!

Frequently Asked Questions (FAQs) for Senior Process Development Engineer Role at Sword Health
What are the responsibilities of a Senior Process Development Engineer at Sword Health?

As a Senior Process Development Engineer at Sword Health, you'll oversee the remote team of engineers and technicians, maintain product manufacturing oversights, design and optimize manufacturing processes, refine statistical process control metrics, and support compliance with regulatory requirements like FDA and ISO standards. You will also play a crucial role in documentation and ensure successful product launches.

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What qualifications do I need to apply for the Senior Process Development Engineer position at Sword Health?

To qualify for the Senior Process Development Engineer role at Sword Health, you need a degree in Mechanical, Manufacturing, or Industrial Engineering, along with a minimum of 8 years of relevant experience in manufacturing for medical devices or a regulated industry. Experience in managing remote teams is vital, as well as strong communication and analytical skills.

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What is the work environment like for a Senior Process Development Engineer at Sword Health?

At Sword Health, the work environment is stimulating and fast-paced, encouraging creativity and innovation. As a Senior Process Development Engineer, you will be part of a dynamic, remote-first company environment that promotes collaboration among teams from various locations, providing opportunities for growth and development in the field.

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Can I work remotely as a Senior Process Development Engineer at Sword Health?

Yes! Sword Health offers a remote or hybrid work policy for the Senior Process Development Engineer position. This flexibility allows you to manage your hours effectively and balance your professional and personal life, aligning with our commitment to employee well-being.

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What are the benefits of working as a Senior Process Development Engineer at Sword Health?

Sword Health provides a comprehensive benefits package, including health, dental, and vision insurance, equity shares, a flexible working environment, and a wellness program featuring digital therapy sessions. Additionally, you’ll enjoy professional growth opportunities and a chance to work in a purpose-driven company that values your contributions.

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Common Interview Questions for Senior Process Development Engineer
What experience do you have in process development for medical devices?

When answering this question, emphasize your direct experience with medical device manufacturing processes, discussing specific projects you've led, challenges you've overcome, and the results achieved. Highlight your understanding of regulatory requirements and how you've ensured compliance in previous roles.

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How do you prioritize tasks in a high-paced environment?

Illustrate your time management strategies, such as using prioritization frameworks like the Eisenhower Matrix. Discuss specific instances where you effectively managed multiple projects and how your organizational skills contributed to the success of your team.

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Can you describe your experience managing remote teams?

Share examples of how you’ve successfully led remote teams, detailing your communication methods, tools used (like Slack or Zoom), and how you fostered a collaborative team culture despite geographical distances. Focus on your leadership style and adaptability.

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What statistical tools are you familiar with for data analysis?

Discuss specific statistical analysis tools and software you’ve used, such as Minitab or R, and give examples of how you've applied statistical methods to improve processes or quality in your previous roles. Mention any successful outcomes achieved through your analytical skills.

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How do you ensure compliance with FDA and ISO regulations during process development?

When responding, mention your familiarity with regulatory requirements and how you implement processes that align with these standards. Provide examples of how you've conducted audits or trained teams on compliance issues in the past.

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What methods do you use for continuous improvement in manufacturing processes?

Talk about methodologies like Lean or Six Sigma that you’ve applied for continuous improvement. Provide examples of process improvements you've initiated, the techniques you employed, and the measurable outcomes from those initiatives.

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Describe a challenging engineering problem you've faced and how you resolved it.

Choose a specific engineering challenge and outline the problem-solving process you used, including how you identified the root cause, the steps you took to develop a solution, and the ultimate impact of resolving that issue on the project or team.

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How do you manage documentation for engineering processes?

Highlight your approach to maintaining accurate and detailed documentation, such as using document management systems, ensuring regular updates, and employing best practices for clarity and accessibility. Illustrate its importance in compliance and knowledge sharing.

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What motivates you to work in the healthcare industry?

Share your passion for improving patient outcomes and how working in the healthcare industry aligns with your values. Discuss specific experiences that have inspired you and how they drive your commitment to making a difference through your engineering work.

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How do you handle pressure and deadlines in a project?

Describe techniques you use to manage stress and stay focused under pressure, such as setting clear goals, breaking tasks into manageable parts, and maintaining open communication with your team. Providing examples will strengthen your response.

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Sword Health is a healthcare company that aims to free 2 billion people from pain by creating the first and only end-to-end global platform to prevent, manage, and treat pain while saving clients millions in healthcare costs.

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Full-time, hybrid
DATE POSTED
December 22, 2024

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