Amsterdam HQ•Publicerad: 16 juli•Sista ansökan: 16 aug.
About myTomorrows
myTomorrows is a global health tech company dedicated to breaking down barriers for patients seeking treatment options.
We strive to enable earlier and better treatment access by bridging the gap between those searching for possible options, and the
companies who develop them. We work closely with patients, healthcare professionals, trial sites, patient advocacy groups, and
BioPharma – connecting key stakeholders in the drug development ecosystem.
We’ve developed a cutting-edge AI-powered technology platform that simplifies and streamlines access to drugs in development. To
support our users and clients, we have a range of industry-expert specialized teams ready to help. Our services include clinical
trial patient recruitment, Expanded Access Program management and Real-World Data collection.
With a global footprint spanning 134 countries, to date we’ve supported over 17,000 patients, 3,000 physicians and 350 sites,
earning the trust of 60+ BioPharma companies. In October 2025, we closed a €25M investment with Avego Healthcare Capital to fuel
our global ambitions and scale the business.
Join us in shaping the future of treatment access - making tomorrow’s therapies accessible for people who need them today.
The Opportunity: Senior Operational Excellence Manager
The Senior Operational Excellence Manager Improves operational processes to enhance efficiency, effectiveness, scalability and
quality across myTomorrows. The role identifies, analyzes, and optimizes business processes using data-driven insights to achieve
sustainable improvements, ensuring processes align with organizational objectives and supporting a culture of continuous
improvement. This role will report to the Director, Operational Excellence (Diane says hi!).
You'll be joining a small Operational Excellence function with a portfolio of active initiatives already in flight. The function
has foundations in place, but there is meaningful room to shape how things are done; this is not a role where you inherit a
fully-defined playbook and execute against it. If you're energized by a mix of picking up existing work and putting your own stamp
on it, this is a strong fit.
This role is hands-on and cross-functional. Success requires strong stakeholder management, excellent documentation discipline,
and the ability to implement change effectively in an environment where teams are busy. The role also serves as a key interface
between Operations and Product Development to ensure operational processes are effectively enabled by systems and tooling,
including AI and automation capabilities.
Key Responsibilities
* Lead operational excellence initiatives: Identify inefficiencies, run root-cause analysis, and deliver scalable process
improvements with measurable outcomes (end-to-end: definition → design → implementation → adoption → tracking).
* Project oversight: Manage scope, plans, dependencies, risks, and stakeholder actions across multiple initiatives to ensure
high-quality delivery and on-time implementation.
* Ops ↔ Product interface (systems enablement): Translate operational needs into clear requirements, support implementation of
system/process changes, and ensure solutions work in real operational workflows.
* AI & automation integration: Identify where AI tools and automation can meaningfully reduce manual effort, improve consistency,
or accelerate throughput.
* Collaborate with the AI/Automation workstream to scope, test, and embed solutions into operational processes — maintaining
appropriate human oversight, especially in regulated contexts.
* Evaluate AI output quality as part of process design, not as an afterthought.
* Lead GxP / CSV related implementations: Partner with Quality and Product to support and/or lead Computer System Validation
(CSV) for GxP-touching systems, ensuring appropriate documentation, test evidence, traceability, training alignment, and change
control as applicable.
* Stakeholder & change management: Influence without authority, align priorities, and drive adoption through practical rollouts
that respect operational workload constraints and provide enablement.
* Documentation excellence: Create and support maintaining high-quality process documentation (process maps, SOPs/work
instructions, templates, decision logs).
* Establish standards and ways of working so teams can document consistently, accurately and keep it current, including how
AI-generated content is reviewed, versioned, and approved.
* Training & embedment: Develop training materials and deliver/coordinate training to ensure process changes are adopted and
sustained including support to the AI enablement team to help build capability in the team’s use of AI tools where relevant.
* Data & KPI management: Define KPIs upfront per initiative; measure, track, analyze trends, and report impact using data
analytics tools.
Requirements
* Experience: 4–6+ years in Operational Excellence / Process Improvement / Operations, with demonstrated success leading
cross-functional improvement initiatives.
* Proven experience operating in validated environments and executing/participating in CSV activities for GxP-touching systems.
* Comfortable working with AI tools in a professional context, not necessarily as a builder, but as a critical and informed user.
* Strong capability in process analysis, continuous improvement methods, and data-driven decision making.
* Experience with project/process management tools; Smartsheet a plus.
* Excellent communication and stakeholder management skills; ability to drive change in fast-paced operational settings.
* Comfortable operating in a maturing function where frameworks are being built, not just inherited.
* Strong writing skills and a high bar for documentation quality; ability to coach and enable others to follow the same
standards.
* Highly preferred: work experience in life sciences (e.g., drug development, expanded access programs, clinical trial
recruitment) and/or highly regulated environments.
Equal opportunities
myTomorrows is an Equal Opportunity Employer and, beyond upholding discrimination-free practices, we are committed to cultivating
a workplace where difference and diversity are protected and celebrated. The best work comes from our best selves, and we go to
great lengths in supporting our team members to be just that.
Providence, RI, USA•Publicerad: 18 juli•Sista ansökan: 17 aug.
About This Role
The Senior Principal Manufacturing Engineer is a technical leader responsible for designing, scaling, and optimizing advanced
manufacturing systems for medical devices, with a strong emphasis on high-volume automation. This role bridges complex product
design with efficient, compliant, large-scale production, leading end-to-end manufacturing strategy from concept through
commercialization.
You will serve as a subject matter expert in automation, process development, and validation in regulated environments, while
mentoring engineering teams and influencing cross-functional decision-making.
What You Will Do
* Lead the design and development of manufacturing processes, production layouts, and automation systems for medical device
assemblies.
* Architect and implement end-to-end automation systems including robotics, vision systems, and SCADA platforms from concept
through commissioning (FAT/SAT)
* Drive scale-up from manual assembly to high-speed, semi-automated or “lights-out” production environments
* Oversee process validation activities including Test Plans, Validation Plans, and IQ/OQ/PQ execution
* Ensure compliance with GMP, ISO 13485, and GxP standards, including documentation such as PFMEAs.
* Analyze and optimize manufacturing processes for yield, throughput, cost reduction, and quality improvements
* Resolve complex technical challenges across manufacturing operations using advanced engineering judgment
* Provide strategic guidance to product design teams to ensure manufacturability and scalability
* Lead and mentor engineering teams; provide technical oversight, coaching, and performance feedback
* Collaborate cross-functionally with R&D, Quality, Supply Chain, and external partners to drive program success
* Contribute to business development initiatives and support client engagements as a technical leader
Required Qualifications
* Bachelor’s degree in mechanical, Manufacturing, Electrical, or related Engineering discipline
* 7–10+ years of experience in medical device, pharmaceutical, or regulated high-volume manufacturing environments
* Deep expertise in automation technologies (robotics, PLCs, machine vision, motion control systems)
* Proven experience designing and scaling automated manufacturing lines
* Strong knowledge of process validation, GMP, ISO 13485, and regulatory compliance
* Advanced proficiency in process development, DOE, and process capability analysis
* Demonstrated ability to solve complex technical problems and lead large-scale initiatives
* Excellent communication and leadership skills, with experience mentoring engineers and influencing stakeholders
* Ability to manage multiple projects and priorities in a fast-paced environment
* On-site work environment in Providence, RI
Preferred Qualifications
* Master’s or PhD in Engineering or related discipline
* Experience implementing “lights-out” or highly automated manufacturing environments
* Expertise with CAD tools and manufacturing simulation software
* Experience working with contract manufacturers and automation vendors
* Background in disposable medical devices, diagnostics, or drug delivery systems
* Familiarity with Computer System Validation (CSV) and digital manufacturing systems
Location
* This is an onsite opportunity with hybrid capabilities in Providence, RI
Providence, RI, USA•Publicerad: 18 juli•Sista ansökan: 17 aug.
About This Role
The Senior Principal Manufacturing Engineer is a technical leader responsible for designing, scaling, and optimizing advanced
manufacturing systems for medical devices, with a strong emphasis on high-volume automation. This role bridges complex product
design with efficient, compliant, large-scale production, leading end-to-end manufacturing strategy from concept through
commercialization.
You will serve as a subject matter expert in automation, process development, and validation in regulated environments, while
mentoring engineering teams and influencing cross-functional decision-making.
What You Will Do
* Lead the design and development of manufacturing processes, production layouts, and automation systems for medical device
assemblies.
* Architect and implement end-to-end automation systems including robotics, vision systems, and SCADA platforms from concept
through commissioning (FAT/SAT)
* Drive scale-up from manual assembly to high-speed, semi-automated or “lights-out” production environments
* Oversee process validation activities including Test Plans, Validation Plans, and IQ/OQ/PQ execution
* Ensure compliance with GMP, ISO 13485, and GxP standards, including documentation such as PFMEAs.
* Analyze and optimize manufacturing processes for yield, throughput, cost reduction, and quality improvements
* Resolve complex technical challenges across manufacturing operations using advanced engineering judgment
* Provide strategic guidance to product design teams to ensure manufacturability and scalability
* Lead and mentor engineering teams; provide technical oversight, coaching, and performance feedback
* Collaborate cross-functionally with R&D, Quality, Supply Chain, and external partners to drive program success
* Contribute to business development initiatives and support client engagements as a technical leader
Required Qualifications
* Bachelor’s degree in mechanical, Manufacturing, Electrical, or related Engineering discipline
* 7–10+ years of experience in medical device, pharmaceutical, or regulated high-volume manufacturing environments
* Deep expertise in automation technologies (robotics, PLCs, machine vision, motion control systems)
* Proven experience designing and scaling automated manufacturing lines
* Strong knowledge of process validation, GMP, ISO 13485, and regulatory compliance
* Advanced proficiency in process development, DOE, and process capability analysis
* Demonstrated ability to solve complex technical problems and lead large-scale initiatives
* Excellent communication and leadership skills, with experience mentoring engineers and influencing stakeholders
* Ability to manage multiple projects and priorities in a fast-paced environment
* On-site work environment in Providence, RI
Preferred Qualifications
* Master’s or PhD in Engineering or related discipline
* Experience implementing “lights-out” or highly automated manufacturing environments
* Expertise with CAD tools and manufacturing simulation software
* Experience working with contract manufacturers and automation vendors
* Background in disposable medical devices, diagnostics, or drug delivery systems
* Familiarity with Computer System Validation (CSV) and digital manufacturing systems
Location
* This is an onsite opportunity with hybrid capabilities in Providence, RI
